The Justice Department says the former CEO of Floridas Pharmatech has been indicted in connection with a 2016 inspection that found traces of B. cepac...
FDA publishes an updated draft guidance on aspects of medical device cybersecurity.
Federal Register notice: FDA makes available a draft ICH guidance entitled M7(R2)Addendum: Application of the Principles of the ICH M7 Guideline to Ca...
Federal Register notice: FDA makes available a final guidance on clinical development recommendations for hepatitis B virus infection drug products.
Bayer asks FDA to confirm that it will apply a 30-month stay to an Apotex ANDA for a generic form of Bayers Astelin nasal spray.
Minerva Neurosciences says FDA continues to have questions and concerns about its proposed NDA for roluperidone to treat negative symptoms of schizoph...
Federal Register notice: FDA seeks comments on an information collection revision entitled Medical Devices; Humanitarian Use Devices 21 CFR Part 814....
FDA publishes a draft guidance in question-and-answer format on using whole slide images in nonclinical toxicology studies.