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With federal action on drug prices and cost transparency stalled in Congress, three states have pushed through their own legislation, with one bill becoming law and another awaiting a governor’s signature. Read More
Less than two weeks on the job and FDA Commissioner Scott Gottlieb is getting pressure from Capitol Hill to change official FDA guidance for compounders. Read More
More drugmakers have weighed in on the FDA’s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy.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