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The pharmaceutical industry’s long — and, so far, fruitless — wait for revisions to the FDA’s electronic recordkeeping requirements, 21 CFR Part 11, is about to get even longer.
The FDA’s long-awaited revision to 21 CFR Part 11 is probably not going to meet the agency’s self-imposed end-of-year deadline, sources close to the FDA tell PIR.
AssurX, a provider of enterprise quality and compliance systems, has launched a new system to help device and drug manufacturers comply with multiple regulatory requirements and manage documents relating to safety issues, customer complaints and supplier quality.
Sage Products, a manufacturer of medical cosmetics, devices and OTC drugs, has seen positive results from a new software system designed to more accurately track its work-in-progress inventory and in-transit materials throughout the supply chain, a company official said.
Wyeth has agreed to support an amendment to a nationwide
legal settlement with users of its fen-phen products -- a move that would guarantee
payments to the largest group of members involved in the class action lawsuit.
American Medical Systems has announced that Martin Emerson has been promoted
to President and CEO from his current role as President and COO. Emerson has
also been appointed to the company's board of directors.
Cardiff, Wales-based Q Chip has signed a new research deal with Biocompatibles
International, a medical device company focused on the treatment of cardiovascular
disease, cancer and benign tumors.