Regulatory Roundup: FDA Issues Warning Letter To Pfizer; And More.

Apr 29, 2010
By PharmTech Editors

Earlier this month, the US Food and Drug Administration issued a Warning Letter to the Global Research and Development division of Pfizer (New York) in London, Connecticut. The letter concerns an investigation that took place in spring 2009 which found that the manufacturer “did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations.” Specifically, FDA pointed out the company’s failure to ensure proper monitoring of the investigation, including compliance with 21 CFR 312.50, and failure to keep investigators informed of new observations reported to the sponsor of the drug regarding adverse effects and safe use. Other recent Warning Letters can be found on the FDA CDER website.

FDA issued a consent decree last week to halt the marketing of an unapproved sterilization system manufactured by Steris (Mentor, OH). The company has been selling tabletop systems for endoscopes and other devices used to sterilize heat-sensitive instruments and medical devices. “When device manufacturers fail to comply with FDA’s regulations, they put patients at increased risk. As this consent decree shows, we will take whatever steps are necessary to make sure that all manufacturers are complying with FDA’s regulations,” said the FDA press release on the consent decree.