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More drugmakers have weighed in on the FDA’s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy. Read More
The FDA warned Chinese API manufacturer Changzhou Jintan Qianyao Pharmaceutical Raw Materials for inadequate quality management and record-keeping. Read More
FDA Commissioner Scott Gottlieb laid out his early priorities before members of Congress Thursday, and announced that the hiring freeze on the agency had officially been lifted. Read More
Sen. Claire McCaskill (D-Mo.) asked Mallinckrodt for more details on price increases for Ofirmev, the company’s injectable version of acetaminophen. Read More