Expanded Access (Compassionate Use) Submission Data Archive: CDRH CDER and CBER Archived Data (2010-2018) CDER and CBER Tables FY 2010 – 2018 Graphs of Expanded Access […]

Each year, CDER receives more than 300,000 submissions, amounting to millions of pieces of data. CDER reviews the data to bring lifesaving new drugs to market […]

On This Page Date: June 18, 2024 Time: 1:00 PM – 2:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT The […]

Use the QR Code to Verify an Electronic Certificate of Pharmaceutical Product Electronic certificates of pharmaceutical product (eCPP) include a unique quick response (QR) code. This […]

FDA and representatives of the generic drug industry meet quarterly to discuss topics related to the implementation of GDUFA.  Minutes from these meetings are posted on […]

The Generic Drug User Fee Amendments of 2012 (GDUFA) was designed to speed access to safe and effective generic drugs to the public and reduce costs […]

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]

On This Page Date: June 27, 2024 Time: 9:00 AM – 4:00 PM ET Attend the public meeting:Registration through Reagan-Udall Foundation The U.S. Food and Drug […]

For Immediate Release: May 07, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]