FDA issues an FDA-483 with eight observations from an inspection at Dr. Reddys drug manufacturing facility in Andhra, Pradesh, India.
FDA grants Emalex Biosciences a fast track designation for its investigational drug ecopipam for treating patients with Tourette Syndrome.
FDA releases a final guidance on use of placebos and blinding in cancer clinical trials.
FDA accepts for review a Viela Bio BLA for inebilizumab, an investigational anti-CD19 monoclonal antibody for treating patients with neuromyelitis opt...
FDA issues a safety alert on three chronic hepatitis drugs after some patients with moderate to severe liver impairment experienced worsening liver fu...
FDA explains new requirements that are part of an upcoming switch to FAERS II that uses changes agreed to in an International Council for Harmonizatio...
CDER director Janet Woodcock and CBER director Peter Marks use an FDA Voices post to defend increases in the use of five congressionally mandated expe...
CDER director Janet Woodcock says the number of people actually exposed to contaminated angiotensin I receptor blockers is likely lower than the numbe...