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,…
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…
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…
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…