Archive for November 2020
UK Establishes New Medical Device Information System
The United Kingdom will launch a new Medical Device Information System (MDIS) in January that aims to improve device monitoring and performance and link them to patient outcomes. Source: The GMP Letter
Read MoreTGA Issues Guidance on Device Conformity Assessments During COVID-19
Australia’s Therapeutic Goods Administration (TGA) said that, in light of delays due to the COVID-19 pandemic and limitations on the number of notified bodies designated under the European Medical Devices Regulation, devicemakers could see their conformance assessment documents lapse for their listed devices on Australia’s Register of Therapeutic Goods. Source: The GMP Letter
Read MoreFDA Issues First Warning Letter for Product With a COVID-19-Related EUA
FDA hit Columbus, Ohio-based Battelle Memorial Institute with a warning letter for failure to comply with terms of its Emergency Use Authorization (EUA) for its decontamination system used for N95 respirators. This marks the first warning letter FDA has sent out regarding a product with a COVID-19-related EUA. Source: The GMP Letter
Read MoreFormer FDA Official Advises on Best GMP practices During the Pandemic
Many of the guidance documents for drug developers and manufacturers that the FDA has issued during the COVID-19 pandemic are likely to continue to be in effect long after the public health emergency has passed, said Keith Webber, a former official in the FDA’s Center for Drug Evaluation and Research and the Center for Biologics…
Read More483 Roundup: Five Drugmakers Cited for Quality Failures
FDA investigators cited five drug facilities for failures ranging from late field reports to lax control of data, complaint handling and training. Source: Drug GMP Report
Read MoreNew Postmarket Reporting Forms Detailed in Draft Guidance
The FDA has developed two new documents that it wants drug sponsors to use for annual postmarket reporting and is requesting comments on them in a new draft guidance. Source: Drug GMP Report
Read MoreWarning Letter Roundup: FDA Raps Three Firms for GMP, Other Lapses
The FDA issued warning letters to three drug manufacturing facilities for failures in their current good manufacturing practices, including lax environmental monitoring and inadequate process validations. Source: Drug GMP Report
Read MoreDr. Reddy’s Temporarily Shutters Data Centers Following Cyber Attack
Dr. Reddy’s Laboratories, one of India’s largest pharmaceutical companies, announced Thursday that it has temporarily shut down all of its data center services in response to a cyberattack. Source: Drug GMP Report
Read MoreGAO Tells FDA It Has Work to Do on Its Office of Laboratory Safety
The Government Accountability Office (GAO) wants the FDA to institute several changes to its three-year-old Office of Laboratory Safety (OLS), which was formed to improve safety in the agency’s labs that work with hazardous biological agents. Source: Drug GMP Report
Read MoreCOVID-19 Vaccine Developers Don’t Need Pre-Approval Inspections for Emergency Use
The FDA will not make COVID-19 vaccine developers go through pre-approval inspections for an Emergency Use Authorization (EUA), but companies will have to submit detailed manufacturing data and meet certain other requirements, said a senior official in the Center for Biologics Evaluation and Research (CBER). Source: Drug GMP Report
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