Simplifying Global Compliance
Articles Tagged with ''FDA''
Two leading House members sent a letter to FDA Commissioner Andrew von Eschenbach asking him when he would have to alert agency employees about possible layoffs if the Prescription Drug User Fee Act (PDUFA) is not reauthorized. Read More
The Centers for Medicare and Medicaid Service’s (CMS) Timothy Stitely will become the FDA’s chief information officer, the agency announced. At the CMS, Stitely served as the director of Information Services Design & Development. Read More
The FDA told RyMed Technologies during a meeting that the firm’s initial response to a Form 483 regarding alleged cGMP violations satisfied the agency’s concerns, according to the firm. Read More
Fisher & Paykel Healthcare violated cGMPs by not documenting the assembly of its CosyCot radiant infant warmers and related accessories to guarantee that the devices meet product specifications, according to an FDA warning letter. Read More
Medical Concepts Development (MCD) failed to take corrective action to address bioburden levels exceeding action/alert thresholds on its surgical drapes, according to a recent FDA warning letter. Read More
Abbott Laboratories is retaining an outside consultant to audit its manufacturing and quality assurance systems at its diagnostics division following a request in a March 13 FDA warning letter, Abbott told GMP. Read More
Manufacturers should approach their responses to Form 483s and FDA warning letters with a global perspective, experts said at a recent FDAnews audioconference. Read More
Pharmacyclics will file a formal protest to require the FDA to review its new drug application (NDA) for its brain cancer treatment. Read More
Sponsors seeking to conduct emergency research under the FDA regulation that allows a waiver of informed consent, or a parallel waiver to the Common Rule issued by the HHS secretary, should address a host of difficult ethical issues and ambiguities while developing the trial protocol, according to an expert. Read More
Last week the FDA posted three separate warning letters to its website citing a sponsor, an investigator and an IRB for a range of violations. Read More
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