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Process validation, according to the FDA’s Quality System Regulation (QSR), means “establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.” In other words: If a devicemaker cannot verify, by inspection or test, that each product specification has been met, the process itself must be tested, to ensure that it yields consistent results. Read More
The FDA handed Elite-Medical a Form 483 for problems with control of nonconforming products and a supplier issue observed during an inspection of its Florence, Ala., facility in April. Read More
The UK’s Department of Health and Social Care is seeking information for an independent review of the potential ethnic bias of certain medical devices such as oximeters and infrared scanners. Read More
After years of trying to pass legislation that would allow the U.S. government to negotiate with drugmakers on prescription drug prices for the Medicare program, the Democrat-controlled U.S. House of Representatives passed such a bill on Friday in a 220-207 vote. Read More
Bavarian Nordic is chiding the FDA after the agency recommended intradermal (ID) administration of Jynneos, the company’s monkeypox vaccine, in its Aug. 11 Emergency Use Authorization (EUA). Read More