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 under 21 ...
The US Food and Drug Administration (FDA) Office of Pharmaceutical Quality (OPQ) of the Center for Drug Evaluation and Research (CDER) recently published a White Paper laying out a framework to ...
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We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
MDR, MDSAP, and FDA audits demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market ...
IRVING, Texas--(BUSINESS WIRE)--Vizient Group Senior Vice President, Pharmacy Solutions Dan Kistner will present at the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER ...
Establishing a corrective and preventive action (CAPA) system is a quality system regulation (QSR) requirement for medical device firms marketing products in the United States. Although FDA has always ...
DexCom said that on Tuesday it received a warning letter from the U.S. FDA following inspections at its facilities in San Diego, Calif., and Mesa, Ariz. related to concerns about manufacturing ...
Purpose-built electronic quality management systems are a better fit for CGT production than traditional technologies.
A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...
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