FDA releases substantive Warning Letters in the last two weeks of December 2025.
FDA releases the form FDA-483 with three observations from an inspection at the Sun Pharmaceutical Medicare sterile drug manufacturing facility in Hal...
A Hyman, Phelps & McNamara CMC regulatory expert lists the initial industry recommendations for improvements to be negotiated in the BsUFA reauthoriza...
FDA accepts for review an Inovio BLA for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis.
FDA seeks input on a new way to contract directly with venture capitalbacked innovators in an effort to possibly speed adoption of emerging technologi...
FDA posts an updated guidance outlining its processes for bioresearch monitoring inspections, which oversee the conduct, reporting, and postmarketing ...
FDA faces Increased scrutiny of its newly established Commissioners National Priority Review voucher program, which is intended to accelerate the revi...
The New York Times reports that ongoing turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope, raising concerns among ...
