May 8, 2024

CDER Data Standards Program

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 […]
May 8, 2024


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 […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0