The Association for Accessible Medicines recommends broadening an FDA draft guidance on some ANDA bioequivalence studies.
The Pew Charitable Trusts say Congress should give FDA authority to regulate some higher-risk laboratory-developed tests.
FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend the agency authorize the use of Pfizers Covid-19 lower-dose vaccin...
Federal Register notice: FDA sends to OMB an information collection revision entitled Registration of Producers of Drugs and Listing of Drugs in Comme...
Eyenovia receives a complete response letter on its NDA for MydCombi (tropicamide and phenylephrine), indicated for in-office pupil dilation, because ...
FDA grants Alkermes a fast track designation for nemvaleukin alfa, an engineered interleukin-2 variant immunotherapy for use in combination with Merck...
CDERs Office of New Drugs says an advisory committee meeting will be convened to review an Avenue Therapeutics dispute resolution request regarding it...
Federal Register notice: FDA announces a 12/10 meeting of the Medical Devices Advisory Committees Neurological Devices Panel that will review a Brains...