Drug GMP Report

Fresenius Kabi Oncology (FKO) has agreed to plead guilty to hiding and destroying records prior to a 2013 FDA inspection and will hand over $50 million in fines and forfeiture, the U.S. Department of Justice revealed. Source: Drug GMP Report

In just over four months, drug manufacturers will experience a change in the FDA’s online adverse event report system to help the agency figure out what stage the product the adverse event is associated with has reached. Source: Drug GMP Report

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. Source: Drug GMP Report

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 straight-to-final guidance released yesterday. Source: Drug GMP Report

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 using a supplier whose drug ingredients had been placed on an import alert. Source: Drug GMP Report

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 materials used to manufacture them. Source: Drug GMP Report

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 Report

The FDA’s Center for Drug Evaluation and Research (CDER) has released its list of planned new and revised guidances for calendar year 2021, an agenda that includes a large number of generic drug-related topics. Source: Drug GMP Report