Designing First-In-Human Trials for Small Molecules and Biologics

Planning for Co-development of Companion Diagnostics

Getting to First-in-Human for Small Molecules and Biologics

Bench to Bedside Chat Pharmacology and Dose Optimization for First-in-Human Oncology Trials

Modeling and Simulation to Select Oncology Dosages - Session 1

Electronic Common Technical Document (eCTD)

FDA Direct: Combating Rare Diseases at the FDA

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

OTC Monograph Reform: OTC Sunscreen Drugs

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

Process Validation and ICH Q7

CMC Considerations for CAR T Cell Product Development

Office of Clinical Pharmacology (OCP): Drugs and Biologics - Bioanalysis 2020

FDA Grand Rounds - Adopting Large Language Models for Regulatory Review

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

FDA Expert Panel on Food Allergies

CMC Considerations for Biotechnology Product Development: A Regulatory Perspective

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

Preclinical Considerations for Cell and Gene Therapy Products, an FDA Perspective

Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017

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