Drugs & Supplements

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Latest FDA News

Generic Drug User Fee Amendments

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

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.

Medical Disclaimer

Drugs A-Z provides drug information from Everyday Health and our partners, as well as ratings from our members, all in one place. Cerner Multum? provides the data within some of the Overview, Uses, Warnings, Side Effects, Pregnancy, Interactions, Dosage, Overdose, and Images sections. The information within all other sections is proprietary to Everyday Health.?