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 removes a clinical hold on Gilead Sciences injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis.
A March FDA inspection of Novel Laboratories (dba Lupin Somerset) leads to a 13-item FDA Form-483 that cites significant and repeat GMP deficiencies.
FDA rejects an emergency use authorization request filed by University of Minnesota Medical School infectious disease physician David Boulware and oth...
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.