Federal Register notice: FDA seeks comments on an information collection extension entitled New Animal Drugs for Investigational Use 21 CFR 511....
Five stakeholders generally praise FDA efforts in a draft guidance on key information and facilitating understanding in informed consent.
CBER director Peter Marks and Brown University medical school professor Eli Adashi say it appears that decentralized clinical trials are a paradigm wh...
A National Mucopolysaccharidoses Society commentary urges FDA to use accelerated approval for promising treatments for rare diseases.
Doctors for America calls on FDA to finalize a guidance on collecting race and ethnicity data in clinical trials and clinical studies.
FDA warns Banten, Indonesia-based P.T. Sankei Medical Industries about Quality System and Medical Device Reporting violations in the manufacturing of ...
FDA approves an Aquestive Therapeutics ANDA for Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of freq...
FDA clears a Spinal Simplicity 510(k) for the Patriot-SI Posterior Implant System as part of a hybrid sacroiliac joint fusion construct.
