FDA and the International Pharmaceutical Regulators Programs Biosimilars Working Group announce a 9/12-13 virtual workshop on increasing the efficienc...
Morgan Lewis attorneys say a recent FDA draft guidance further demonstrates the agencys interest in modernizing good clinical practice guidelines to r...
Federal Register notice: FDA seeks comments on an information collection extension entitled Good Laboratory Practice Requirements for Nonclinical Labo...
Federal Register notice: FDA sends to OMB an information collection revision entitled Investigational New Drug Application Requirements.
Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Devices; Device Tracking 21 CFR Part 821.
FDA warns six overseas manufacturers of over-the-counter drugs about CGMP violations.
CBER begins a phased implementation of in-person industry meetings with device manufacturers.
The Biotechnology Innovation Organization says it supports FDA efforts to promote stakeholder discussion on the role of artificial intelligence and ma...
