A clinical investigator failed to supervise a drug clinical trial she was conducting, delegating her responsibilities to a site management organization whose CEO committed multiple violations, according to an FDA warning letter.
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.
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.
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.
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.
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.