On September 19, 2025, the Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years […]

[9-18-2025] The Food and Drug Administration is advising consumers not to purchase or use Primal Herbs Volume, a product promoted and sold for sexual enhancement on […]

Docket Number: FDA-2011-D-0164 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The Food and Drug Administration (FDA […]

On This Page Date: October 15 – 16, 2025 Day1: Wed, Oct 15 8:30 a.m. – 05:00 p.m. ET Day2: Thu, Oct 16 8:30 a.m. – […]

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)