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More drugmakers have weighed in on the FDA’s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy.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
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
A television advertisement for the Orexigen Therapeutics weight loss drug Contrave (naltrexone HCl and bupropion HCl) drew a warning from the FDA’s Office of Prescription Drug Promotion (OPDP), the office’s first of 2017. Read More
FDA Commissioner Scott Gottlieb pitches the agency’s proposed fiscal 2018 budget to House appropriators on Capitol Hill today, as industry and other stakeholders voice their concerns over the impact of the administration’s proposal. Read More
Scott Gottlieb, in one of his first official acts as FDA commissioner, established an opioid policy steering committee to review the agency’s drug review policies and explore possible actions to lower abuse. Read More
President Trump’s budget for fiscal 2018 proposes a “recalibration” of how the FDA funds its core mission of ensuring the safety of drugs, which would cut its federal spending by $854 million, to be replaced with $866 million in industry user fees. Read More