A new study published in JAMA Health Forum suggests the market for compounded GLP-1 weight-loss drugs remains robust despite the FDA's resumption of e...
In a mid-year enforcement update, Arnold Golden Gregory partner Gabriel Scannapieco says FDA and the Department of Justice are increasingly extending ...
A 7/20 opinion article contends that FDA acting commissioner Kyle Diamantas has outlined a broad vision for modernizing FDA by emphasizing innovation,...
FDA issues an Early Alert warning healthcare providers about a potentially high-risk issue involving certain Baxter Duo-Vent solution sets that could ...
FDA issues a Form-483 to Charles River Laboratories' Endosafe contract testing laboratory in Charleston, SC, over multiple quality system deficiencies...
A new study suggests that direct-to-consumer prescription drug Web sites may better communicate the limitations of FDA accelerated approvals when disc...
FDA cites Fujifilm Diosynth Biotechnologies USA for significant manufacturing deficiencies at its drug substance facility in Research Triangle Park, N...
FDA accepts for review a Camurus NDA resubmission for Oclaiz (octreotide), a long-acting injection for treating acromegaly.