Managing drug treatments for children may call for communicating with them via Facebook, videos or comics, the European Medicines Agency said in draft guidance on pharmacovigilance practices for pediatric populations.…
A federal judge shut down a Salt Lake City drug compounder Aug. 3 under a consent decree issued in a case brought by the FDA after inspections uncovered numerous regulatory…
The FDA finalized 48 guidances for generics manufacturers, outlining the recommended studies for demonstrating bioequivalence for dozens of active ingredients and combinations, to assist the industry with generating evidence to…
The FDA updated the status of a voluntary field removal notice for Penumbra’s 3D revascularization device, designating it as a Class I recall. Source: The GMP Letter
Six device manufacturing facilities landed Form 483s from the FDA after inspections turned up numerous problems with their CAPA, complaint, training and other procedures. Source: The GMP Letter
Medical device quality managers that don’t want to wind up a statistic in a future FDA report on quality deviations should dig deeply into the agency’s recently released report on…
Brazil’s National Surveillance Agency has added Ireland’s standards authority to its list of accredited organizations to perform quality management system audits under the Medical Device Single Audit Program. Source: The…
The FDA finalized its list of 1,003 class II medical devices low-risk enough to be exempt from 510(k) requirements, but stressed that all devices, exempt or otherwise, are subject to…
The FDA warned National Biological Corp. for failure to thoroughly investigate complaints and improper handling of out-of-spec products. Source: The GMP Letter
Whitehall Manufacturing received a warning letter for multiple violations concerning its whirlpool immersion hydrotherapy and dry heat therapy devices. Source: The GMP Letter