Electronic Common Technical Document (eCTD)

CDER NextGen Portal

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

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

Electronic Common Technical Document (eCTD) and Study Data (7of15) RedI – May 29-30, 2019

CMC Considerations for Biotechnology Product Development: A Regulatory Perspective

Understanding FDA Inspections and Data

FDA Expert Panel on Food Allergies

OTC Monograph Reform: OTC Sunscreen Drugs

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

FDA Grand Rounds - Antibody Glycosylation Insights for High Quality Biotherapeutics

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

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

FDA Grand Rounds - Adopting Large Language Models for Regulatory Review

Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017

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

FDA's Public Meeting on Food Allergen Thresholds - 02/18/2026

FDA Grand Rounds - Forensic Proteomics Applied to FDA Regulated Products

Process Validation and ICH Q7

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

Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence