Drugs & Supplements

FDA is soliciting general comments on GDUFA II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA Program Fees in a timely manner. FDA has begun an inventory of all approved ANDAs, and has assembled a spreadsheet that lists all ANDA holders and the number of ANDAs associated with each entity. FDA is seeking general feedback on whether the information in this spreadsheet is accurate and complete.

The Brief Summary is a monthly bulletin intended for all OPDP stakeholders. Started in January 2022, The Brief Summary provides news and updates related to OPDP.

Regulating the use of radioactive drugs in basic research

Providing Over-the-Counter Monograph Submissions in Electronic Format

GDUFA Guidances and MAPPs