FDAs Peripheral and Central Nervous System Drugs Advisory Committee votes 6 to 4 that data from a single randomized, controlled trial and an open-labe...
Federal Register notice: FDA sends to OMB an information collection extension entitled Financial Disclosure by Clinical Investigators.
FDA releases an executive summary that provides more details on the package of legislative proposals that were included in the agencys FY 2023 budget ...
The federal Cybersecurity & Infrastructure Security Agency identifies a vulnerability in the Philips e-Alert MRI monitoring platform.
FDA releases the FDA-483 issued following two 2017 inspections at Chinas Zhejiang Hisun Pharmaceutical Company.
FDA warns Salinas, Puerto Rico-based Agropharma Laboratories about repeat CGMP violations in its production of finished drugs.
FDA authorizes a second booster dose of the Pfizer and Moderna Covid-19 vaccines for older adults and some immunocompromised people.
FDA warns Mazowieckie, Poland-based Dr Retter Ec Wladyslaw Retter about CGMP violations in its production of over-the-counter drugs.