FDA co-chairs with the EMA a global regulators meeting on developing vaccines to address the Covid-19 pandemic.
FDA warns Chinas Hangzhou Likeweier Daily Chemical Co. about CGMP violations in its production of finished drugs as a contract manufacturer.
FDA warns Denmarks DermaPharm about CGMP violations in its manufacturing of finished drugs.
CBER solicits clinical trials to study using Covid-19 convalescent plasma as a treatment for the virus and says it is facilitating making it available...
Two stakeholders suggest changes to an FDA draft guidance on demonstrating substantial evidence of drug and biological product effectiveness.
FDA releases its latest batch of Warning Letters that includes Hangzhou Linkeweier Daily Chemicals and DermaPharm A/S.
Faced with many challenges to the healthcare system during the coronavirus outbreak, Eli Lilly decides to delay most new study starts and pauses enrol...
Federal Register notice: FDA publishes a final guidance entitled Submission of Plans for Cigarette Packages and Cigarette Advertisements.