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Two FDA advisory committees recommended the FDA approve KemPharm’s opioid pill Apadaz, even though they rejected an abuse-deterrent label for the candidate. Read More
Drugmakers and trade groups overwhelmingly want lower user fees and a clearer review process for GDUFA as the FDA looks to renew the user fees before the Sept. 30, 2017 cut-off date. Read More
The House Appropriations Committee passed a fiscal 2017 agricultural appropriations bill in April that proposes a slight funding increase for the FDA, but still remains well below the agency’s funding request. Read More
Several days after Valeant Pharmaceuticals International executives pledged to establish a committee to review its drug pricing practices, the Senate Aging Committee released a treasure trove of documents related to the company’s internal pricing strategies. Read More
Valeant Pharmaceuticals International has established a drug pricing committee, a move that comes a week after company representatives pledged to review its pricing model in the face of withering congressional criticism. Read More