API Facility Inspections

Responses to Submitted Poster Questions - Drug Master File (DMF) and Drug Substance Workshop

FDA Drug Manufacturing Inspections - REdI 2020

FDA Grand Rounds - Adopting Large Language Models for Regulatory Review

Facility Readiness: GMPs, Quality Assessments, and Compliance Trends (15of16) GDF 2020

FDA Expert Panel on Testosterone Replacement Therapy for Men

Importing FDA-Regulated Products: Human Foods

Medical Device Quality Management System Regulation Design and Development

Conversations on Cancer – Perspectives on Cancer Care Decision-Making Among Older Adults

FDA Grand Rounds - Advancing Real World Evidence in FDA Regulatory Decision Making

OTC Monograph Reform: OTC Sunscreen Drugs

FDA Grand Rounds - Postmarket Regulation of Cosmetic Products: The Who, What, When, Why, and How

Drug Master File (DMF) Submissions on New FDA Form 3938

FDA Grand Rounds - Statistical Considerations for Drug Development in Rare Disease

FDA Celebrates 120 Years

January 22, 2026: Tobacco Products Scientific Advisory Committee Meeting

FDA Grand Rounds - Antibody Glycosylation Insights for High Quality Biotherapeutics

Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017

FDA-USP-AAM | D1S3 - Industry’s Engagement in USP’s Standards-Setting Process

503B Product Reporting for Compounding Outsourcing Facilities (7/7) Drug Registration & Listing 2018

FDA-USP-AAM | D1S1 – FDA's Participation in USP-NF Revision Process – Challenges and Solutions