Advancing Generic Drug Development: Translating Science to Approval Keynote Address Janet Woodcock, MDActing Commissioner of Food and DrugsFood and Drug Administration COVID-19 Impact on Generic Drug […]

On This Page Date: December 15, 2021 Time: 3:00 p.m. – 4:00 p.m. ET Visit CDER Small Business and Industry Assistance Page [embedded content] ABOUT THIS […]

[9/7/2022] FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have accepted the agency’s first submission into the Innovative […]

[9/24/2024] FDA’s Center for Drug Evaluation and Research (CDER) has accepted the first letter of intent (LOI) into the Innovative Science and Technology Approaches for New […]

Discussions with key Center for Drug Evaluation and Research (CDER) leadership about important regulatory and policy issues Content current as of: 03/26/2025 Regulated Product(s)

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

Product: Drugs Recipient: Recipient Name Maziar Mike Doustdar Recipient Title President and Chief Executive Officer Novo Nordisk Inc. 800 Scudders Mill RoadPlainsboro, NJ 08536United States Issuing […]

Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States […]

Product: Drugs Recipient: Recipient Name Josh Disbrow Recipient Title Chief Executive Officer Aytu Biopharma 7900 E. Union Avenue, Suite 920Denver, CO 80237United States Issuing Office: Center […]