Pharmaceutical and medical device manufacturers should not assume that recent staff cuts at the US Food and Drug Administration (FDA) mean the agency will inspect less often and take fewer enforcement ...
Free 5-minute assessment finds drug supply chain gaps before the FDA does. Built for med spas, dermatology, ophthalmology, and optometry. We pride ourselves on running a compliant practice, Claritas ...
From home purchases to FDA audits, inspections hinge on one thing: the record they leave behind. Incomplete or vague documentation can cost money, reputation, and even legal standing. Whether you're a ...
Food and Drug Administration warning letters to food manufacturers, sellers and importers have been trending upward, and the shift is not incidental. It reflects a maturing regulatory environment ...
WASHINGTON – The top compliance official at the US Food and Drug Administration’s (FDA) biologics center said it is imperative for sponsors to schedule preapproval inspections (PAIs) at the midpoint ...
Cathy Burgess, Yifan Wang, Ph.D. Our FDA: Compliance & Enforcement Team examines a new FDA compliance program for Center for Drug Evaluation and Research (CDER)-regulated biologics, highlighting the ...
On Feb. 1, 2026, the FDA officially launched its Manufacturing PreCheck Pilot Program, which is intended to de-risk and accelerate the establishment of U.S. pharmaceutical manufacturing facilities by ...
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