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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
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
The FDA is considering establishing a new office for patient affairs to support the agency’s efforts to engage patients in the drug development process. Read More
The administration’s plan to nominate Scott Gottlieb as FDA commissioner drew generally positive reactions on Capitol Hill and from drugmakers — but also some concerns from other stakeholders over his strong industry ties. Read More
The 505(b)(2) approval pathway, designed to expedite reviews, actually takes about five months longer than the standard NDA process, says a new report from the Tufts Center for the Study of Drug Development. Read More