FDA releases a list of 13 potential safety signals identified in drugs between 7/2025 and 9/2025.
In a PDUFA 8 reauthorization subgroup discussion, FDA and industry representatives trade data and evaluations of first-cycle reviews and debate whethe...
FDA posts a guidance on Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, D...
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...
