FDA publishes a guidance on using patient engagement to support the design and conduct of medical device clinical studies.
Federal Register notice: FDA announces a 3/3 Vaccines and Related Biological Products Advisory Committee meeting that will select strains to be includ...
CBER releases a list of 13 guidances it is considering developing in 2022.
FDA tells Soleno Therapeutics that an additional clinical trial is necessary before the company submits an NDA for once-daily DCCR (diazoxide choline)...
Pfizer and BioNTech begin a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate.
FDA publishes a guidance on using patient-reported outcome instruments in medical device evaluation.
FDA warns Chino, CA-based Health Plus about CGMP violations in its manufacturing of finished pharmaceuticals.
Four stakeholders suggest changes to a draft FDA guidance on using electronic health records and claims data to support drug and biologic regulatory d...