Regulatory Affairs Professionals Society

FDA warns device maker, contract testing lab for GMP violations

The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for ...
Becker's Hospital Review

Lawmakers propose bill to revamp FDA’s medical device inspections

Senators this week introduced a bipartisian bill that would update the Food and Drug Administration’s process for inspecting medical devices. The bill — sponsored by Sens. Michael Bennet, D-Colo., and ...

MERIT Announces Successful FDA Inspection

We are very proud of this result. A no‑483 outcome is a testament to the discipline, expertise, and dedication of our ...
Nasdaq

EBR Systems Awaits FDA Inspection for Wireless Cardiac Device

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MD&M East

Medical Device Companies Must Navigate Historic FDA Rule Change

On Monday, February 2, a new final rule from FDA changing QMS requirements for medical devices went into effect. Manufacturers have had over two years to comply with the new rule, which is now full ...
Reno Gazette-Journal

FDA Foreign Inspection Gap Grows as U.S. Drug Imports Surge, New Study Finds

Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study quantifies a decade of oversight gaps. We first need rigorous, replicable ways to ...