Health Canada has issued new guidance for devicemakers on submitting “summary reports” and conducting issue-related analyses of safety and effectiveness for devices approved for marketing in Canada — two requirements…
The FDA has released a new action plan that outlines a potential approach to premarket reviews for artificial intelligence (AI) and machine learning-(ML) software modifications. Source: The GMP Letter
The FDA’s Center for Devices and Radiological Health (CDRH) is getting ready to launch its Accreditation Scheme for Conformity Assessment (ASCA) pilot program allowing accredited testing laboratories to assess the…
The Center for Drug Evaluation and Research (CDER) is set to reorganize its Office of Generic Drugs (OGD) to help keep up with the high volume of generic drug applications.…
Internal European Medicines Agency (EMA) documents on pending approvals of COVID-19 vaccines were hacked and leaked online, the agency said. Source: Drug GMP Report
The FDA is calling for risk assessments by cell and gene therapy (CGT) manufacturers to minimize the potential for transmitting the SARS-CoV-2 virus through their products, according to a new…
FDA investigators observed a variety of quality lapses during inspections of four drug manufacturing facilities. Source: Drug GMP Report
The FDA called on drug compounders to know their active pharmaceutical ingredient (API) suppliers as it issued a warning letter to Houston, Texas-based Professional Compounding Centers of America (PCCA) for…
Yuyao YiJia Daily Chemical, an over-the-counter drug manufacturer in Ningbo, China, drew a warning letter from the FDA for not adequately testing its products, their active ingredients and the raw…
The FDA issued straight-to-final guidance that provides sponsors of monoclonal antibody and other therapeutic protein COVID-19 treatments with recommendations for potency assays to ensure consistent product quality. Source: Drug GMP…