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 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.
Bolton Medical recalls its Relay Pro Thoracic Stent Graft Systems due to reports of a deployment failure that may result in serious injury or death.
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 releases the form FDA-483 with 13 observations from an April inspection at Chinas Zhejiang Hushai Pharmaceutical Co.
