Division of Clinical Research

Jan-March 2021 CDER Meetings and Conferences

January

• Jan. 14 CDER Compliance Conference
• Jan. 26 Non-clinical Immunogenicity Assessment of Generic Peptide Products: Development, Validation, and Sampling
• Jan. 27 OTC Monograph Reform in the CARES Act: Safety Orders, Webinar
• Jan. 27 Public Meeting: Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act
• Jan. 29 Regulatory Perspectives for Development of Drugs for Treatment of NASH, Webinar

February

• Feb. 9 Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

March

• Mar. 3-4 Drug Master File (DMF) and Drug Substance Workshop
• Mar. 8 Public Meeting on Patient-Focused Drug Development for Vitiligo
• Mar. 30-31 Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups

Categories FDA Regulatory
Tagged Compliance Conference, DMF, FDA, NASH, Oncology, training, webinars