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Companies want to be able to choose between providing quality metric reports on a more comprehensive product-by-product or less burdensome site-by-site basis. Read More
A Chinese API maker relied on manipulated data and incomplete records to make decisions on batch releases, prompting the FDA to issue a warning letter to the company over data integrity. Read More
More than four years after adopting an ICH guideline on manufacturing processes, the FDA has responded to industry questions on starting materials for chemical entity drug substances. Read More
Pick and Pay, also doing business as Cili Minerals, was ordered to cease operations by a federal district judge for GMP violations until it gets written permission from the FDA to resume. Read More
The FDA hit Pfizer’s Hospira for failing to fully investigate quality defects, such as the presence of cardboard, in batches of injections and neglecting to take corrective measures. Read More
Former FDA deputy commissioner Scott Gottlieb emerged as the favorite to serve as the next leader of the FDA in a survey of 53 pharmaceutical companies. Read More
An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More
McKesson has agreed to pay a record civil penalty of $150 million to settle DEA and Justice Department allegations that the drug distributor failed to report suspicious orders of opioids. Read More
Srikem Laboratories, an India-based active pharmaceutical ingredient manufacturer has been hit with a Form 483 after an inspection showed a number of repeat observations. The firm failed to meet established specifications, laboratory control procedures and equipment failures. Read More