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The FDA is honing in on roughly eight to 10 quality metrics that the agency plans to collect from drugmakers starting in 2015, and expects to publish a guidance that names them by the end of the year. Read More
Within two years, the FDA will begin assigning all facility inspections to specialized teams that have detailed expertise in the lifecycle of the particular drug that is subject to inspection. Read More
FDA investigators and their European counterparts are comparing training and auditing procedures as the first steps in a new push to increase mutual reliance on each other’s inspections. Read More
A Chinese active pharmaceutical ingredient (API) maker was slammed by the FDA for falsifying batch record signoffs and product labeling, the latest international drugmaker to be caught in the agency’s crackdown on poor data integrity. Read More
The FDA warned a Georgia-based compounder and repackager for poor cleaning practices that apparently led to patients becoming infected by contaminated products. Read More
The FDA warned a Georgia-based compounder and repackager for poor cleaning practices that apparently led to patients becoming infected by contaminated products. Read More
FDA investigators and their European counterparts are comparing training and auditing procedures as the first steps in a new push to increase mutual reliance on each other’s inspections. Read More
The FDA is honing in on roughly eight to 10 quality metrics that the agency plans to collect from drugmakers starting in 2015, and expects to publish a guidance that names them by the end of the year. Read More
Manufacturers operating in Europe should report any product-quality defect to the drug application holders and individual EU regulatory bodies if the incident requires a recall or creates supply restrictions, according to a revised chapter of a European Commission guideline on good manufacturing practices. Read More
British regulators have revised their recommendations on the reporting of pediatric adverse drug reactions to focus on severe or serious events, a change that addressed complaints that the previous system was overly burdensome. Read More
Marcus Research Laboratory was handed a Form 483 for not performing stability testing or properly monitoring the production process for the active pharmaceutical ingredient iodine. Read More