Federal Register notice: FDA makes available a final guidance entitled Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.
Senators Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) introduce legislation entitled the Retaining Access and Restoring Exclusivity (RARE) Act, which ...
The Senate HELP Committee releases a discussion draft of a bill that would reauthorize user fee programs for another five years and enhance certain ot...
FDA accepts for priority review a Travere Therapeutics NDA for sparsentan and its use in treating IgA nephropathy.
Federal Register notice: FDA debars for five years Howard Stanley Head from importing or offering for import any drug into the U.S.
FDA posts a final guidance entitled Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
Avanos Medical recalls (Class 1) its Cortrak 2 Enteral Access System due to reports of injuries and patient deaths after nasoenteric or nasogastric tu...
FDA issues an Emergency Use Authorization (EUA) for the Labcorps Covid-19+Flu+RSV Test Home Collection Kit for use with the Labcorp Seasonal Respirato...