Latest FDA News

FDA Roundup: August 9, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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

What's New Related to Drugs

Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.

FDA Approves First Nasal Spray for Treatment of Anaphylaxis

The FDA approved the first nasal spray for the emergency treatment of allergic reactions, including those that are life-threatening, in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds).

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