A Cooley legal analysis notes that FDA and federal prosecutors are signaling a tougher stance on failures to report patient safety issues to regulator...
FDA warns Alsip, IL-based GC America about CGMP violations in its production of finished drugs.
FDA extends its review of an AstraZeneca NDA for camizestrant, an experimental breast cancer therapy, after requesting additional data tied to a close...
Corcept Therapeutics plans to resubmit its NDA for relacorilant as a treatment for patients with Cushings syndrome, following additional analyses requ...
FDA approves an AbbVie NDA for Decnupaz (pivekimab sunirine-pvzy) and its use in treating adults with blastic plasmacytoid dendritic cell neoplasm.
NSF consultants report on a webinar discussing the best practices in responding to inspection observations in a form FDA-483.
A Yale Journal on Regulation article from the Yale Law School Solomon Center for Health Law & Policy examines how the Supreme Courts Loper Bright deci...
FDA warns Indias Alchymars ICM SM Private Limited about CGMP deviations in its production of active pharmaceutical ingredients.
