Change Management: ICH Q12 and Established Conditions (12of33) Quality – Oct. 16-17, 2019

Panel Questions and Discussion (13of33) Quality – Oct. 16-17, 2019

Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020

ICH Q11 Q&A - A Supporting Document for the Selection and Justification of Starting Materials

ICH Q12: What Industry Needs to Know – Pharmaceutical Quality Symposium 2023

ICH Q12 Guidance and Emerging Technology Program (11of16) Generic Drugs Forum 2020

Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6of14) REdI 2018

Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA - REdI 2020

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

Continuous Manufacturing of Drug Product (20of33) Quality – Oct. 16-17, 2019

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

Drug Substance Quality Assessment: Best Practices (23of27) Generic Drugs Forum 2018

eCTD Submissions of Promotional Labeling and Advertising Materials

Framework for FDA’s Real-World Evidence Program – Mar 15, 2019

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

FDA-USP-AAM | D1S2 – Strengthening Your Compendial Strategy

FDA Celebrates 120 Years

FDA Direct: Combating Rare Diseases at the FDA

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

FDA Direct: Combating Rare Diseases at the FDA

FDA Grand Rounds - Adopting Large Language Models for Regulatory Review