News

PharmTech1d
3 Reasons FDA Says Quality Investments Are Essential for Drug Manufacturers and Patients
FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and ...
JD Supra1y
FDA Releases Final Quality Management System Regulation Amendments
The U.S. Food and Drug Administration (FDA) issued a final rule on Jan. 31, 2024, to amend the medical device current good manufacturing practice requirements of the quality system regulation ...
JD Supra1y
U.S. device makers get 2 years to comply with FDA Quality Management ...
FDA has just published a 101-page rule titled “ Medical Devices; Quality System Regulation Amendments,” finalizing the February 2022 proposed rule of the same name.
FDA Knew Drugmaker Had Poor Record. It Waited Four Years to Inspect One Factory.
Glenmark’s backlogged testing “was overdue by 3 months or longer for a large proportion of your samples,” the FDA wrote in ...
Nasdaq6mon
Integra LifeSciences reports FDA warning letter related to quality ...
In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...