www.fda.gov ↗︎
221 Pages Found
Science and History of GMOs and Other Food Modification Processes
www.fda.gov/food/agricultural-biotechnology/science-and-history-gmos-and-other-food-modification-processes
Last glasped on May 22, 2023
4 users
Accelerated Approval
www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval
Last glasped on Aug 23, 2023
3 users
HACCP Principles & Application Guidelines
www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines
Last glasped on Jan 22, 2024
3 users
Spilling the Beans: How Much Caffeine is Too Much?
www.fda.gov/consumers/consumer-updates/spilling-beans-how-much-caffeine-too-much
Last glasped on Oct 7, 2024
2 users
FDA 101: Dietary Supplements
www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements
Last glasped on Oct 14, 2024
2 users
Listeria (Listeriosis)
www.fda.gov/food/foodborne-pathogens/listeria-listeriosis
Last glasped on Jun 4, 2024
2 users
FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease
www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease
Last glasped on Dec 14, 2023
2 users
UPDATE: Recalled Philips Respironics Ventilators, BiPAPs, and CPAPs
www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due
Last glasped on Jul 18, 2023
2 users
FDA approves treatment of ALS associated with a mutation in the supero
www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-amyotrophic-lateral-sclerosis-associated-mutation-sod1-gene
Last glasped on Nov 27, 2023
2 users
Medical X-ray Imaging | FDA
www.fda.gov/radiation-emitting-products/medical-imaging/medical-x-ray-imaging
Last glasped on Mar 23, 2023
2 users
FDA Approves Add-On Therapy to Lower Cholesterol In Certain People
www.fda.gov/drugs/news-events-human-drugs/fda-approves-add-therapy-lower-cholesterol-among-certain-high-risk-adults
Last glasped on Mar 14, 2024
2 users
Pulse Oximeters and Oxygen Concentrators: What to Know
www.fda.gov/consumers/consumer-updates/pulse-oximeters-and-oxygen-concentrators-what-know-about-home-oxygen-therapy
Last glasped on May 2, 2023
2 users
How GMO Crops Impact Our World
www.fda.gov/food/agricultural-biotechnology/how-gmo-crops-impact-our-world
Last glasped on Jul 4, 2022
2 users
FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine
www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine
Last glasped on Sep 11, 2023
2 users
Aspartame and Other Sweeteners in Food
www.fda.gov/food/food-additives-petitions/aspartame-and-other-sweeteners-food
Last glasped on Oct 24, 2023
2 users
DHHS Letterhead
www.fda.gov/media/136534/download
Last glasped on Apr 3, 2020
1 users
FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests
www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests
Last glasped on May 9, 2024
1 users
Products and Medical Procedures
www.fda.gov/medical-devices/products-and-medical-procedures
Last glasped on Jul 27, 2023
1 users
Postmarket Requirements (Devices)
www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/postmarket-requirements-devices
Last glasped on Oct 10, 2024
1 users
Class I and Class II Device Exemptions
www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions
Last glasped on Apr 30, 2024
1 users
Lyophilization of Parenteral (7/93)
www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/lyophilization-parenteral-793
Last glasped on Jun 13, 2024
1 users
FSMA Final Rule on Requirements for Additional Traceability Records
www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods
Last glasped on Feb 19, 2024
1 users
FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees
www.fda.gov/news-events/press-announcements/fda-commissioner-makary-announces-new-policy-individuals-serving-fda-advisory-committees
Last glasped on Apr 17, 2025
1 users
FDA Approves New Antibiotic for Three Different Uses
www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses
Last glasped on May 6, 2025
1 users
Drug Trials Snapshots: LEQEMBI
www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-leqembi
Last glasped on Oct 18, 2024
1 users
Compounding Laws and Policies
www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies
Last glasped on Aug 14, 2024
1 users
FDA approves lazertinib with amivantamab-vmjw for NSCLC
www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lazertinib-amivantamab-vmjw-non-small-lung-cancer
Last glasped on Sep 30, 2024
1 users
Infusion Pumps
www.fda.gov/medical-devices/general-hospital-devices-and-supplies/infusion-pumps
Last glasped on Apr 8, 2025
1 users
Oncology Burst
www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant
Last glasped on Jun 23, 2023
1 users
Be Aware of Potentially Dangerous Products and Therapies
www.fda.gov/consumers/consumer-updates/be-aware-potentially-dangerous-products-and-therapies-claim-treat-autism
Last glasped on Jul 24, 2024
1 users
Emergency Preparedness and Medical Devices
www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-preparedness-and-medical-devices-supply-chain-recommendations-health-care-providers-device
Last glasped on Dec 22, 2023
1 users
FDA grants accelerated approval to adagrasib for colorectal cancer
www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-adagrasib-cetuximab-kras-g12c-mutated-colorectal-cancer
Last glasped on Sep 14, 2024
1 users
FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved
www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated
Last glasped on Mar 27, 2024
1 users
Science & Research (Biologics)
www.fda.gov/vaccines-blood-biologics/science-research-biologics
Last glasped on Mar 21, 2025
1 users
Advancing evidence generation for oncology medical products
www.fda.gov/about-fda/oncology-center-excellence/project-pragmatica
Last glasped on Sep 9, 2024
1 users
FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy
www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-children-metachromatic-leukodystrophy
Last glasped on Mar 22, 2024
1 users
Recalls small number of acne products for benzene contamination
www.fda.gov/drugs/drug-safety-and-availability/limited-number-voluntary-recalls-initiated-after-fda-testing-acne-products-benzene-findings-show
Last glasped on Apr 4, 2025
1 users
FDA approves amivantamab-vmjw with carboplatin and pemetrexed
www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-carboplatin-and-pemetrexed-non-small-cell-lung-cancer-egfr-exon-19
Last glasped on Sep 30, 2024
1 users
Decentralized Clinical Trials for Drugs, Biological Products, and Devices Draft Guidance for Industry, Investigators, and Other Stakeholders - 25036308dft.pdf
www.fda.gov/media/167696/download
Last glasped on May 21, 2024
1 users
FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs
Last glasped on Apr 11, 2025
1 users
Cigarettes
www.fda.gov/tobacco-products/products-ingredients-components/cigarettes
Last glasped on Mar 2, 2023
1 users
Summary of Cosmetics Labeling Requirements
www.fda.gov/cosmetics/cosmetics-labeling-regulations/summary-cosmetics-labeling-requirements
Last glasped on Mar 26, 2024
1 users
Sherlock CRISPR SARS-CoV-2 Kit - Instructions for Use - EUA-Sherlock-cris-ifu.pdf
www.fda.gov/media/137746/download
Last glasped on Mar 18, 2024
1 users
What You Need to Know about Foodborne Illnesses
www.fda.gov/food/consumers/what-you-need-know-about-foodborne-illnesses
Last glasped on Mar 1, 2025
1 users
CDRH Draft Guidance on Change Control Plans for AI/ML-Enabled Devices
www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-issues-draft-guidance-predetermined-change-control-plans-artificial-intelligencemachine
Last glasped on Apr 8, 2023
1 users
FSMA Final Rule on Sanitary Transportation of Human and Animal Food
www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-sanitary-transportation-human-and-animal-food
Last glasped on Mar 21, 2024
1 users
Small Businesses & Homemade Cosmetics: Fact Sheet
www.fda.gov/cosmetics/resources-industry-cosmetics/small-businesses-homemade-cosmetics-fact-sheet
Last glasped on Mar 26, 2024
1 users
Notice to Industry: Postmarketing Requirements - Postmarket studies and clinical trials | FDA
www.fda.gov/drugs/guidance-compliance-regulatory-information/notice-industry-postmarketing-requirements-postmarket-studies-and-clinical-trials
Last glasped on Apr 1, 2024
1 users
Drug Master Files: Guidelines
www.fda.gov/drugs/guidances-drugs/drug-master-files-guidelines
Last glasped on Jul 9, 2024
1 users
Model-Integrated Evidence Pilot Program
www.fda.gov/drugs/abbreviated-new-drug-application-anda/model-integrated-evidence-mie-industry-meeting-pilot-between-fda-and-generic-drug-applicants
Last glasped on Apr 26, 2024
1 users
MOU 225-24-023 with EPA/Office of Pesticide Programs, CDC, and USDA
www.fda.gov/about-fda/domestic-mous/mou-225-24-023
Last glasped on May 5, 2025
1 users
Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Briefing Document - FDA - VRBPAC-12.17.20-Meeting-Briefing-Document-FDA_0.pdf
www.fda.gov/media/144434/download
Last glasped on Nov 14, 2023
1 users
Tanning Products
www.fda.gov/radiation-emitting-products/tanning/tanning-products
Last glasped on Aug 4, 2022
1 users
FDA Roundup: March 7, 2023
www.fda.gov/news-events/press-announcements/fda-roundup-march-7-2023
Last glasped on Mar 7, 2023
1 users
FDA approves osimertinib
www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-chemotherapy-egfr-mutated-non-small-cell-lung-cancer
Last glasped on Sep 30, 2024
1 users
Code of Federal Regulations - Title 21 - Food and Drugs
www.fda.gov/medical-devices/medical-device-databases/code-federal-regulations-title-21-food-and-drugs
Last glasped on Dec 9, 2024
1 users
Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
www.fda.gov/advisory-committees/advisory-committee-calendar/march-14-2024-meeting-oncologic-drugs-advisory-committee-meeting-announcement-03142024
Last glasped on Feb 1, 2024
1 users
U.S. Smokeless Tobacco Company MRTP Application
www.fda.gov/tobacco-products/advertising-and-promotion/us-smokeless-tobacco-company-modified-risk-tobacco-product-mrtp-application
Last glasped on Mar 16, 2023
1 users
Dietary Supplements
www.fda.gov/food/dietary-supplements
Last glasped on Nov 10, 2024
1 users
Frequently Asked Questions About Therapeutic Biological Products
www.fda.gov/drugs/therapeutic-biologics-applications-bla/frequently-asked-questions-about-therapeutic-biological-products
Last glasped on Mar 16, 2025
1 users
Considerations for the Development of Chimeric Antigen Receptor T Cell Products; Guidance for Industry - Considerations-for-Development-of-Chimeric-Antigen-Receptor-T-Cell-Products_January-2024.pdf
www.fda.gov/media/156896/download
Last glasped on Jan 3, 2025
1 users
Investigational New Drug (IND) Application
www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application
Last glasped on Apr 17, 2024
1 users
FDA grants regular approval to fam-trastuzumab deruxtecan-nxki for bre
www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-fam-trastuzumab-deruxtecan-nxki-breast-cancer
Last glasped on Sep 1, 2023
1 users
Why Do Farmers in the U.S. Grow GMO Crops?
www.fda.gov/food/agricultural-biotechnology/why-do-farmers-us-grow-gmo-crops
Last glasped on May 22, 2023
1 users
Laboratory Developed Tests: Frequently Asked Questions
www.fda.gov/medical-devices/laboratory-developed-tests/laboratory-developed-tests-frequently-asked-questions
Last glasped on May 9, 2024
1 users
IDE Approval Process
www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process
Last glasped on Aug 29, 2024
1 users
Prescription Dispensing Laboratories, Inc. dba PD Labs - 579286 - 07/30/2019
www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prescription-dispensing-laboratories-inc-dba-pd-labs-579286-07302019
Last glasped on Oct 9, 2024
1 users
New Qualified Health Claims for EPA and DHA Omega-3
www.fda.gov/food/hfp-constituent-updates/fda-announces-new-qualified-health-claims-epa-and-dha-omega-3-consumption-and-risk-hypertension-and
Last glasped on Nov 6, 2024
1 users
¿Qué regula la FDA?
www.fda.gov/about-fda/what-we-do/que-regula-la-fda
Last glasped on Jan 3, 2025
1 users
Artificial Intelligence
www.fda.gov/science-research/focus-areas-regulatory-science-report/focus-area-artificial-intelligence
Last glasped on Nov 5, 2024
1 users
Postmarketing Requirements and Commitments: Introduction
www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarket-requirements-and-commitments
Last glasped on Mar 20, 2024
1 users
Microplastics and Nanoplastics in Foods
www.fda.gov/food/environmental-contaminants-food/microplastics-and-nanoplastics-foods
Last glasped on Sep 5, 2024
1 users
Medical Device Reporting (MDR): How to Report Medical Device Problems
www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
Last glasped on May 26, 2024
1 users
How Cows Eat Grass
www.fda.gov/animal-veterinary/animal-health-literacy/how-cows-eat-grass
Last glasped on Oct 26, 2024
1 users
Division of Standards and Conformity Assessment
www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/division-standards-and-conformity-assessment
Last glasped on Oct 10, 2024
1 users
FDA approves treatment for adults with Alzheimer’s disease
www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease
Last glasped on Oct 19, 2024
1 users
Sodium in Your Diet
www.fda.gov/food/nutrition-education-resources-materials/sodium-your-diet
Last glasped on Apr 6, 2024
1 users
Designating an Orphan Drug or Biologic
www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products
Last glasped on Aug 23, 2023
1 users
Tanning Pills
www.fda.gov/cosmetics/cosmetic-products/tanning-pills
Last glasped on Aug 4, 2022
1 users
Outbreak Investigation
www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-o121h19-organic-carrots-november-2024
Last glasped on Nov 30, 2024
1 users
Priority Review
www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review
Last glasped on Mar 31, 2024
1 users
Danger: Don’t Drink Miracle Mineral Solution or Similar Products
www.fda.gov/consumers/consumer-updates/danger-dont-drink-miracle-mineral-solution-or-similar-products
Last glasped on Jul 23, 2023
1 users
Changes to the Nutrition Facts Label
www.fda.gov/food/food-labeling-nutrition/changes-nutrition-facts-label
Last glasped on May 23, 2024
1 users
FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment
www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment
Last glasped on Oct 18, 2024
1 users
lisocabtagene maraleucel
www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/breyanzi-lisocabtagene-maraleucel
Last glasped on Mar 5, 2024
1 users
Structure/Function and Related Claims in Dietary Supplement Labeling
www.fda.gov/food/information-industry-dietary-supplements/notifications-structurefunction-and-related-claims-dietary-supplement-labeling
Last glasped on Nov 17, 2024
1 users
CGMPs for Food and Dietary Supplements
www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements
Last glasped on May 31, 2023
1 users
Personal Importation For Import Program
www.fda.gov/industry/import-basics/personal-importation
Last glasped on Nov 16, 2024
1 users
Drug Quality Sampling and Testing Programs
www.fda.gov/drugs/science-and-research-drugs/drug-quality-sampling-and-testing-programs
Last glasped on Feb 16, 2023
1 users
How FDA Plans to Help Consumers Capitalize on Advances in Science
www.fda.gov/news-events/fda-voices/how-fda-plans-help-consumers-capitalize-advances-science
Last glasped on Nov 15, 2024
1 users
FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014
www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014
Last glasped on Sep 26, 2023
1 users
Food Irradiation: What You Need to Know
www.fda.gov/food/buy-store-serve-safe-food/food-irradiation-what-you-need-know
Last glasped on Aug 1, 2023
1 users
E-Cigarettes, Vapes, and other ENDS
www.fda.gov/tobacco-products/products-ingredients-components/e-cigarettes-vapes-and-other-electronic-nicotine-delivery-systems-ends
Last glasped on Mar 2, 2023
1 users
Evaluation and Definition of Potentially Hazardous Foods - Evaluation-and-Definition-of-Potentially-Hazardous-Foods.pdf
www.fda.gov/files/food/published/Evaluation-and-Definition-of-Potentially-Hazardous-Foods.pdf
Last glasped on Apr 2, 2023
1 users
Over-the-Counter (OTC) Drugs Branch: The OTC Drug Review
www.fda.gov/drugs/enforcement-activities-fda/over-counter-otc-drugs-branch-otc-drug-review
Last glasped on Aug 2, 2022
1 users
Enhancing Benefit-Risk Assessment in Regulatory Decision-Making
www.fda.gov/industry/prescription-drug-user-fee-amendments/enhancing-benefit-risk-assessment-regulatory-decision-making
Last glasped on Feb 5, 2024
1 users
FDA approves Xermelo for carcinoid syndrome diarrhea
www.fda.gov/news-events/press-announcements/fda-approves-xermelo-carcinoid-syndrome-diarrhea
Last glasped on Mar 31, 2023
1 users
FDA approves Enhertu for HER2-positive gastric adenocarcinomas
www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-positive-gastric-adenocarcinomas
Last glasped on Sep 1, 2023
1 users
Plan with your doctor before taking FDA-approved asthma medicines
www.fda.gov/consumers/consumer-updates/manage-your-asthma-know-your-triggers-and-treatment-options
Last glasped on Mar 10, 2023
1 users
Cronobacter sakazakii
www.fda.gov/food/foodborne-pathogens/cronobacter-sakazakii
Last glasped on Aug 12, 2023
1 users
Patient Empowerment in the Digital Health Era
www.fda.gov/news-events/speeches-fda-officials/speech-robert-m-califf-md-2023-science-patient-engagement-symposium-patient-empowerment-digital
Last glasped on May 8, 2023
1 users
Questions & Answers
www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd-questions-answers
Last glasped on Sep 14, 2022
1 users
FDA Requests Removal of All Ranitidine Products (Zantac) from the Market
www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
Last glasped on Nov 25, 2023
1 users
Antimicrobial Resistance
www.fda.gov/animal-veterinary/safety-health/antimicrobial-resistance
Last glasped on Apr 9, 2023
1 users
CPG Sec. 230.150 BloodDonorClassificationStatement, PaidorVolunteerDonor.pdf
www.fda.gov/media/75039/download
Last glasped on Oct 25, 2023
1 users
How to Understand and Use the Nutrition Facts Label
www.fda.gov/food/new-nutrition-facts-label/how-understand-and-use-nutrition-facts-label
Last glasped on Mar 30, 2023
1 users
Coronavirus (COVID-19) | Drugs
www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs
Last glasped on Dec 8, 2022
1 users
Philips Recalls Some DreamStations for Inaccurate/Insufficient Therapy
www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-reworked-dreamstation-cpap-bipap-machines-risk-they-may-deliver
Last glasped on Jul 17, 2023
1 users
The Risks of Tanning
www.fda.gov/radiation-emitting-products/tanning/risks-tanning
Last glasped on Aug 3, 2022
1 users
Xenotransplantation
www.fda.gov/vaccines-blood-biologics/xenotransplantation
Last glasped on Apr 3, 2023
1 users
FDA approves tisagenlecleucel
www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisagenlecleucel-relapsed-or-refractory-follicular-lymphoma
Last glasped on Aug 14, 2022
1 users
Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS
www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/guidance-industry-computerized-systems-used-clinical-trials
Last glasped on Mar 29, 2023
1 users
Pre-Existing Tobacco Products
www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/pre-existing-tobacco-products
Last glasped on Mar 17, 2023
1 users
Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals - FDA-FSVP-Guidance-January2023-12162022-1300.pdf
www.fda.gov/media/118241/download
Last glasped on Oct 26, 2023
1 users
Regulatory Mechanisms for Marketing OTC Drug Products
www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/regulatory-mechanisms-marketing-otc-drug-products
Last glasped on Aug 2, 2022
1 users
Clinical Trials and Human Subject Protection
www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection
Last glasped on Jul 31, 2023
1 users
Tanning
www.fda.gov/radiation-emitting-products/radiation-emitting-products-and-procedures/tanning
Last glasped on Aug 1, 2022
1 users
Premarket Tobacco Product Applications
www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications
Last glasped on Mar 17, 2023
1 users
The Bad Ad Program
www.fda.gov/drugs/office-prescription-drug-promotion/bad-ad-program
Last glasped on Sep 18, 2023
1 users
Harvey Wiley
www.fda.gov/about-fda/fda-leadership-1907-today/harvey-wiley
Last glasped on Jan 25, 2024
1 users
Collaboration and Innovation Stimulated Advancement in Generics
www.fda.gov/news-events/fda-voices/collaboration-and-scientific-innovation-stimulated-advancement-generic-drug-program-2022
Last glasped on Mar 3, 2023
1 users
Milk and Plant-Based Milk Alternatives: Know the Nutrient Difference
www.fda.gov/consumers/consumer-updates/milk-and-plant-based-milk-alternatives-know-nutrient-difference
Last glasped on Mar 6, 2023
1 users
Social media challenges that misuse OTC drugs are dangerous to kids
www.fda.gov/consumers/consumer-updates/recipe-danger-social-media-challenges-involving-medicines
Last glasped on Sep 22, 2022
1 users
FDA permits marketing of first medical device for treatment of ADHD
www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-medical-device-treatment-adhd
Last glasped on Oct 23, 2023
1 users
Smokeless Tobacco Products
www.fda.gov/tobacco-products/products-ingredients-components/smokeless-tobacco-products-including-dip-snuff-snus-and-chewing-tobacco
Last glasped on Mar 16, 2023
1 users
Makena (hydroxyprogesterone caproate injection) Information
www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/makena-hydroxyprogesterone-caproate-injection-information
Last glasped on Apr 6, 2023
1 users
FDA Approves First Generic of Restasis
www.fda.gov/news-events/press-announcements/fda-approves-first-generic-restasis
Last glasped on Dec 1, 2022
1 users
FDA Roundup: March 14, 2023
www.fda.gov/news-events/press-announcements/fda-roundup-march-14-2023
Last glasped on Mar 15, 2023
1 users
FDA Authorizes Copenhagen Classic Snuff to be Marketed as a Modified Risk Tobacco Product
www.fda.gov/news-events/press-announcements/fda-authorizes-copenhagen-classic-snuff-be-marketed-modified-risk-tobacco-product
Last glasped on Mar 16, 2023
1 users
Philips Respironics CPAP, BiPAP, and Ventilator Recall: FAQs
www.fda.gov/medical-devices/safety-communications/faqs-philips-respironics-ventilator-bipap-machine-and-cpap-machine-recalls
Last glasped on Jul 17, 2023
1 users
FDA Regulation of Animal Drugs
www.fda.gov/animal-veterinary/resources-you/fda-regulation-animal-drugs
Last glasped on Jan 24, 2024
1 users
Neurology Program: Research on Neurology Medical Devices
www.fda.gov/medical-devices/medical-device-regulatory-science-research-programs-conducted-osel/neurology-program-research-neurology-medical-devices
Last glasped on Mar 29, 2024
1 users
CDRH Mission, Vision and Shared Values
www.fda.gov/about-fda/center-devices-and-radiological-health/cdrh-mission-vision-and-shared-values
Last glasped on Apr 7, 2024
1 users
FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure
www.fda.gov/news-events/press-announcements/fda-approves-first-medication-help-reduce-allergic-reactions-multiple-foods-after-accidental
Last glasped on Apr 16, 2024
1 users
Surrogate Endpoints
www.fda.gov/drugs/development-resources/surrogate-endpoint-resources-drug-and-biologic-development
Last glasped on Apr 1, 2024
1 users
Fast Track
www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
Last glasped on Mar 9, 2024
1 users
"Hypoallergenic" Cosmetics
www.fda.gov/cosmetics/cosmetics-labeling-claims/hypoallergenic-cosmetics
Last glasped on Aug 22, 2024
1 users
Patient Advocacy Lies at Heart of FDA Agent’s Theranos Case
www.fda.gov/about-fda/regulatory-news-stories-and-features/patient-advocacy-lies-heart-fda-agents-theranos-case
Last glasped on Apr 13, 2025
1 users
FDA approves osimertinib for non-small cell lung cancer
www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-locally-advanced-unresectable-stage-iii-non-small-cell-lung-cancer
Last glasped on Sep 30, 2024
1 users
Ozempic Drug Trial Snapshot
www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-ozempic
Last glasped on Jan 21, 2025
1 users
Per- and Polyfluoroalkyl Substances (PFAS)
www.fda.gov/food/environmental-contaminants-food/and-polyfluoroalkyl-substances-pfas
Last glasped on Mar 9, 2024
1 users
Use of Data Monitoring Committees in Clinical Trials - 8204696dftrv1.pdf
www.fda.gov/media/176107/download
Last glasped on Feb 28, 2024
1 users
Information for Consumers on Using Dietary Supplements
www.fda.gov/food/dietary-supplements/information-consumers-using-dietary-supplements
Last glasped on Oct 14, 2024
1 users
Facts about Dietary Supplements
www.fda.gov/news-events/rumor-control/facts-about-dietary-supplements
Last glasped on Jul 24, 2023
1 users
(COVID-19 Vaccine, mRNA)
www.fda.gov/vaccines-blood-biologics/comirnaty
Last glasped on Sep 29, 2023
1 users
FDA Issues Final Guidance Action Levels for Lead
www.fda.gov/food/hfp-constituent-updates/fda-issues-final-guidance-industry-action-levels-lead-processed-food-intended-babies-and-young
Last glasped on Feb 16, 2025
1 users
Division of Pharmacometrics
www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/division-pharmacometrics
Last glasped on May 1, 2024
1 users
Non-Invasive Body Contouring Technologies
www.fda.gov/medical-devices/aesthetic-cosmetic-devices/non-invasive-body-contouring-technologies
Last glasped on Dec 10, 2024
1 users
FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint
www.fda.gov/news-events/press-announcements/fda-finalizes-enforcement-policy-unauthorized-flavored-cartridge-based-e-cigarettes-appeal-children
Last glasped on Jun 9, 2024
1 users
Gudiance on Developing and Using Data Bases for Nutrition Labeling
www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-guide-developing-and-using-data-bases-nutrition-labeling
Last glasped on Jul 25, 2024
1 users
Lead in Food and Foodwares
www.fda.gov/food/environmental-contaminants-food/lead-food-and-foodwares
Last glasped on Feb 16, 2025
1 users
MMC Healthcare Ltd. - 684644 - 09/24/2024
www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mmc-healthcare-ltd-684644-09242024
Last glasped on Oct 20, 2024
1 users
Structure/Function Claims
www.fda.gov/food/nutrition-food-labeling-and-critical-foods/structurefunction-claims
Last glasped on Nov 17, 2024
1 users
FDA’s Approach to Regulation of Nanotechnology Products
www.fda.gov/science-research/nanotechnology-programs-fda/fdas-approach-regulation-nanotechnology-products
Last glasped on Aug 14, 2024
1 users
Sunless Tanners & Bronzers
www.fda.gov/cosmetics/cosmetic-products/sunless-tanners-bronzers
Last glasped on Aug 4, 2022
1 users
How GMOs Are Regulated
www.fda.gov/food/agricultural-biotechnology/how-gmos-are-regulated-united-states
Last glasped on May 19, 2023
1 users
Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Revie
www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
Last glasped on May 3, 2025
1 users
CDER Clinical, CDTL, and Division Summary Memo: Hadlima (adalimumab-bwwd) - 11-761059s6-adalimumab-bwwd-clinical-prea.pdf
www.fda.gov/media/170699/download
Last glasped on Mar 27, 2025
1 users
FDA Guidance Provides New Details on Diversity Action Plans Required for Certain Clinical Studies
www.fda.gov/news-events/press-announcements/fda-guidance-provides-new-details-diversity-action-plans-required-certain-clinical-studies
Last glasped on Jun 26, 2024
1 users
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
Last glasped on May 4, 2025
1 users
Jury Concludes Holmes Perpetrated Scheme to Defraud Investors
www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/doj-press-releases-involving-fda-oci/theranos-founder-elizabeth-holmes-found-guilty-investor-fraud
Last glasped on Apr 3, 2025
1 users
Breakthrough Therapy
www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
Last glasped on Mar 31, 2024
1 users
FDA approves selumetinib for neurofibromatosis type 1 with symptomatic
www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-neurofibromatosis-type-1-symptomatic-inoperable-plexiform-neurofibromas
Last glasped on Jun 21, 2024
1 users
Appearance and Performance Enhancing Substances Simulated Conversation
www.fda.gov/drugs/safe-use-initiative/appearance-and-performance-enhancing-substances-simulated-conversation-health-professionals
Last glasped on May 5, 2024
1 users
Overdose Prevention Activities Timeline
www.fda.gov/drugs/food-and-drug-administration-overdose-prevention-framework/timeline-selected-fda-activities-and-significant-events-addressing-substance-use-and-overdose
Last glasped on Apr 14, 2025
1 users
FDA-EMA Parallel Scientific Advice Pilot Program
www.fda.gov/drugs/generic-drugs/fda-ema-parallel-scientific-advice-pilot-program-complex-generichybrid-products
Last glasped on Mar 16, 2024
1 users
Generic Drugs: Questions & Answers
www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs-questions-answers
Last glasped on Apr 9, 2025
1 users
Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine Review Memo - Pfizer-COVID-19 Vaccine EUA review memo_508ed_0.pdf
www.fda.gov/media/144416/download
Last glasped on Nov 14, 2023
1 users
1,4-Dioxane in Cosmetics
www.fda.gov/cosmetics/potential-contaminants-cosmetics/14-dioxane-cosmetics-manufacturing-byproduct
Last glasped on Jul 11, 2024
1 users
The Impact of Direct-to-Consumer Advertising
www.fda.gov/drugs/information-consumers-and-patients-drugs/impact-direct-consumer-advertising
Last glasped on Oct 3, 2023
1 users
What influences healthcare providers’ prescribing decisions? Results from a national survey - Research-in-Social-and-Administrative-Pharmacy.pdf
www.fda.gov/media/151256/download
Last glasped on Dec 13, 2024
1 users
Artificial Intelligence and Machine Learning in Software
www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device
Last glasped on May 6, 2024
1 users
What is Digital Health?
www.fda.gov/medical-devices/digital-health-center-excellence/what-digital-health
Last glasped on Sep 24, 2023
1 users
Approved Drug Products with Therapeutic Equivalence Evaluations (Orang
www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
Last glasped on Jan 24, 2024
1 users
Modified Risk Tobacco Products
www.fda.gov/tobacco-products/advertising-and-promotion/modified-risk-tobacco-products
Last glasped on Mar 17, 2023
1 users
Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical D
www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices
Last glasped on May 6, 2024
1 users
COA Grant Program
www.fda.gov/drugs/development-approval-process-drugs/cder-pilot-grant-program-standard-core-clinical-outcome-assessments-coas-and-their-related-endpoints
Last glasped on Nov 26, 2024
1 users
Pyrogens, Still a Danger
www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/pyrogens-still-danger
Last glasped on Jul 17, 2024
1 users
FDA Roundup: February 28, 2023
www.fda.gov/news-events/press-announcements/fda-roundup-february-28-2023
Last glasped on Mar 1, 2023
1 users
FDA approves entrectinib for NTRK solid tumors and ROS-1 NSCLC
www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-entrectinib-ntrk-solid-tumors-and-ros-1-nsclc
Last glasped on Oct 25, 2023
1 users
Cosmetics Safety Q&A: Animal Testing
www.fda.gov/cosmetics/resources-consumers-cosmetics/cosmetics-safety-qa-animal-testing
Last glasped on Dec 30, 2023
1 users
FDA Releases Two Discussion Papers on AI and ML
www.fda.gov/news-events/fda-voices/fda-releases-two-discussion-papers-spur-conversation-about-artificial-intelligence-and-machine?utm_source=substack
Last glasped on May 11, 2023
1 users
FDA's Implementation of Menu Labeling Moving Forward
www.fda.gov/food/food-labeling-nutrition/fdas-implementation-menu-labeling-moving-forward
Last glasped on Feb 8, 2023
1 users
Novel Drug Approvals for 2020
www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2020
Last glasped on Jun 22, 2023
1 users
Clinical Review Memo, August 23, 2021 - COMIRNATY - Clinical Review Memo, August 23, 2021 - COMIRNATY.pdf
www.fda.gov/media/152256/download?attachment
Last glasped on Sep 29, 2023
1 users
Proposed Rule: Quality System Regulation Amendments – FAQs
www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/proposed-rule-quality-system-regulation-amendments-frequently-asked-questions
Last glasped on Apr 9, 2022
1 users
FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena
www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-scientist-announce-decision-withdraw-approval-makena
Last glasped on Apr 6, 2023
1 users
Premarket Approval (PMA)
www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma
Last glasped on May 12, 2023
1 users
FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating
Last glasped on Sep 29, 2023
1 users
Real Kosher Ice Cream Recalls Soft Serve on the Go Cups Because of Possible Health Risk
www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/real-kosher-ice-cream-recalls-soft-serve-go-cups-because-possible-health-risk
Last glasped on Aug 14, 2023
1 users
Real-World Evidence
www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
Last glasped on Oct 30, 2023
1 users
FDA List of Authorized Generic Drugs
www.fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugs
Last glasped on Aug 23, 2023
1 users
GMOs and the Environment
www.fda.gov/food/agricultural-biotechnology/gmos-and-environment
Last glasped on May 22, 2023
1 users
Design Controls
www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/design-controls
Last glasped on Mar 27, 2023
1 users
Bisphenol A (BPA): Use in Food Contact Application
www.fda.gov/food/food-packaging-other-substances-come-contact-food-information-consumers/bisphenol-bpa-use-food-contact-application
Last glasped on Dec 9, 2023
1 users
CPG Sec 562.100 Acetic Acid
www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-562100-acetic-acid-use-foods-labeling-foods-which-used
Last glasped on Jan 16, 2024
1 users
BAM Chapter 2: Microscopic Examination of Foods
www.fda.gov/food/laboratory-methods-food/bam-chapter-2-microscopic-examination-foods
Last glasped on Mar 11, 2023
1 users
UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Corona
www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/uv-lights-and-lamps-ultraviolet-c-radiation-disinfection-and-coronavirus
Last glasped on Apr 6, 2023
1 users
Transdermal Drug Products Report
www.fda.gov/industry/generic-drug-user-fee-amendments/fys-2013-2017-gdufa-science-and-research-report-transdermal-drug-products
Last glasped on Jan 31, 2024
1 users
Medicamentos Genéricos: Preguntas y Respuestas
www.fda.gov/drugs/generic-drugs/medicamentos-genericos-preguntas-y-respuestas
Last glasped on Nov 2, 2023
1 users
FDA approves fam-trastuzumab deruxtecan-nxki for HER2-low breast cance
www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-low-breast-cancer
Last glasped on Sep 1, 2023
1 users
FDA's Drug Review Process: Continued
www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-continued
Last glasped on Oct 3, 2023
1 users
CLIA Waiver by Application Decision Summaries
www.fda.gov/about-fda/cdrh-transparency/clia-waiver-application-decision-summaries
Last glasped on Jul 28, 2023
1 users
Table of Substrates, Inhibitors and Inducers
www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers
Last glasped on Jul 28, 2023
1 users
Arsenic, Cadmium, Chromium, Cobalt, Lead, Mercury, and Nickel Content
www.fda.gov/cosmetics/potential-contaminants-cosmetics/fdas-testing-cosmetics-arsenic-cadmium-chromium-cobalt-lead-mercury-and-nickel-content
Last glasped on Mar 20, 2023
1 users
Results from the annual National Youth Tobacco Survey (NYTS)
www.fda.gov/tobacco-products/youth-and-tobacco/results-annual-national-youth-tobacco-survey
Last glasped on Nov 8, 2023
1 users
What is a Medical Device Recall?
www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall
Last glasped on Jul 17, 2023
1 users
Microbiological Safety and Cosmetics
www.fda.gov/cosmetics/potential-contaminants-cosmetics/microbiological-safety-and-cosmetics
Last glasped on Feb 27, 2024
1 users
Agricultural Biotechnology
www.fda.gov/food/consumers/agricultural-biotechnology
Last glasped on Jul 4, 2022
1 users
Guidance on Complementary and Alternative Medicine Products
www.fda.gov/regulatory-information/search-fda-guidance-documents/complementary-and-alternative-medicine-products-and-their-regulation-food-and-drug-administration
Last glasped on May 20, 2022
1 users
FDA Releases Two Discussion Papers on AI and ML
www.fda.gov/news-events/fda-voices/fda-releases-two-discussion-papers-spur-conversation-about-artificial-intelligence-and-machine
Last glasped on May 11, 2023
1 users
Conducting Remote Regulatory Assessments Questions and Answers
www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-remote-regulatory-assessments-questions-and-answers
Last glasped on Feb 16, 2023
1 users
Forward Into the Past With FDA’s New History Exhibit
www.fda.gov/news-events/fda-voices/forward-past-fdas-new-history-exhibit
Last glasped on Jan 25, 2024
1 users
Product Problems
www.fda.gov/safety/reporting-serious-problems-fda/product-problems
Last glasped on Feb 13, 2024
1 users
Facilitating Review of Real-World Data Studies: The Oncology QCARD
www.fda.gov/news-events/fda-voices/facilitating-review-real-world-data-studies-oncology-qcard-initiative
Last glasped on Jun 30, 2023
1 users
Convalescent Plasma
www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-covid-19-convalescent-plasma
Last glasped on Jun 16, 2023
1 users
Science and the Regulation of Biological Products
www.fda.gov/about-fda/histories-product-regulation/science-and-regulation-biological-products
Last glasped on Apr 10, 2023
1 users
FDA Approves First Gene Therapy to Treat Adults with Hemophilia B
www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treat-adults-hemophilia-b
Last glasped on Aug 16, 2023
1 users
FDA and Kratom
www.fda.gov/news-events/public-health-focus/fda-and-kratom
Last glasped on Aug 24, 2023
1 users
Pembrolizumab (KEYTRUDA) Checkpoint Inhibitor
www.fda.gov/drugs/resources-information-approved-drugs/pembrolizumab-keytruda-checkpoint-inhibitor
Last glasped on Oct 25, 2023
1 users
The Bad Ad Program
www.fda.gov/drugs/office-prescription-drug-promotion/bad-ad-program?utm_source=canva&utm_medium=iframely
Last glasped on Sep 18, 2023
1 users
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