Search List of Extended Use Dates to Assist with Drug Shortages
This is to update and consolidate the extended use date information posted previously to assist with drug shortage (6/15/17 to…
More Spotlight on CDER Science Articles
FDA scientists carry out laboratory, clinical and analytical research to address knowledge gaps in drug development, healthcare technologies and post-market…
FDA updates guidance on interchangeability
FDA issued a draft guidance for industry “Considerations for Demonstrating Interchangeability with a Reference Product: Update.” Learn more.
9 Things to Know About Biosimilars and Interchangeable Biosimilars
FDA experts share some interesting facts about to biosimilars and interchangeable biosimilars.
Advancing Clinical Trial Participation for the LGBTQIA+ Community
Representatives of the FDA were fortunate to attend a community discussion on advancing clinical trial diversity for sexual and gender…
Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act
This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for…
Withdrawn and Expired Guidances | Drugs
Withdrawn and Expired Guidances | Drugs
FDA/Center for Research on Complex Generics (CRCG) Workshop on Modeling and Artificial Intelligence (AI) in Generic Drug Development and Product Lifecycle Management: Regulatory Insights and Future Trends – 10/15/2025
This 2-day hybrid (virtual and in-person) workshop focuses on exploring the opportunities, applications, and regulatory considerations of Artificial Intelligence (AI)…
Advancing Generic Drug Development: Translating Science to Approval – 09/21/2021
KEYNOTE SPEAKER – Janet Woodcock MD, Acting Commissioner of FDA
Understanding CDER’s Postmarket Safety Surveillance Programs and Public Data
CDER Conversation: Understanding CDER’s Postmarket Safety Surveillance Programs and Public Data