Federal Register notice: FDA announces a 3/28-29 a joint advisory committee meeting to discuss proposed changes to the isotretinoin iPLEDGE Risk Evalu...
Two pharmaceutical associations suggest ways to clarify an International Council on Harmonization draft guidance on evaluating the viral safety of bio...
Federal Register notice: FDA issues an order permanently debarring Gabriel J. Letizia, Jr from providing services related to an approved or pending dr...
Federal Register notice: FDA determines that Mallinckrodts Ofirmev (acetaminophen) injection, 1,000 mg/100 ml, was not withdrawn for safety or effecti...
FDA denies a citizen petition from advocacy group Public Citizen that urged it and the Drug Enforcement Administration to open proceedings to place ga...
Merck says it has identified the root cause of nitrosamine formation in certain Januvia (sitagliptin) batches.
Federal Register notice: FDA classifies prognostic tests for assessing liver-related disease progression into Class 2 (special controls).
The HHS Inspector General says FDA has concurred with recommendations on steps to improve its management of IT acquisition contracts.
