FDA publishes a draft guidance to assist drug sponsors planning to conduct clinical studies in neonates.
FDA makes available a draft guidance entitled E8(R1) General Considerations for Clinical Studies.
FDA and HHS issue a plan with two potential paths for importing certain drugs from foreign countries, but Canadians object.
FDA releases the FDA-483 with seven inspection observations issued following an agency inspection at the Cipla Virgonagar, India, API manufacturing si...
FDA approves a Bayer NDA for Nubeqa (darolutamide), an androgen receptor inhibitor for treating patients with non-metastatic castration-resistant pros...
Federal Register notice: FDA sends to OMB an information collection extension for Information that should be included with Humanitarian Device Exempti...
Federal Register notice: FDA seeks comments on an information collection extension for biological and cell product deviation reporting.
FDA posts the FDA-483 issued following an inspection at the Dr. Reddys Unit 2 API manufacturing facility in Andhra Pradesh, India.