FDA issues a draft guidance with questions and answers for two International Council for Harmonization guidances.
FDA awards a $5 million grant to two universities to create a Center for Research on Complex Generics.
The HHS Inspector General says REMS are not well suited to quickly address the opioid crisis and makes four recommendations to improve their use.
Former FDA principal deputy commissioner Joshua Sharfstein and two co-authors suggest four ways FDA could recommit to greater transparency in Covid-19...
Federal Register notice: FDA seeks comments on an information collection extension for Generic Clearance for the Collection of Qualitative Data on Tob...
Federal Register notice: FDA announces the renewal of its Cardiovascular and Renal Drugs Advisory Committee for an additional two years.
FDA warns Indias Panacea Biotec about CGMP violations in its production of finished drugs.
FDA warns Intrathecal Compounding about deficiencies in its production of sterile drugs.