FDA warns Liebel-Flarsheim in Raleigh, NC, about CGMP violations in its production of finished drugs.
FDA releases the form FDA-483 with four observations from an inspection at the Alembic Pharmaceuticals active pharmaceutical ingredient manufacturing ...
A STAT report highlighted in Medpage says CBER employees are concerned about the environment established by their new director, Vinay Prasad.
FDA issues Biohaven a complete response letter, rejecting the companys NDA for Vyglxia (troriluzole) as a treatment for spinocerebellar ataxia.
FDA issues a Warning Letter to Apotex, citing significant GMP violations at the companys Richmond Hill, Ontario, facility, including failures in steri...
FDA warns Waunakee, WI-based Scientific Protein Laboratories about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Politico reports that President Trump and HHS are standing by FDA commissioner Marty Makary as the agency weathers the sudden departure of CDER direct...
FDA approves a Meitheal Pharmaceuticals NDA for Contepo (fosfomycin) for injection for treating adults with complicated urinary tract infections.
