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The White House’s proposed budget for fiscal 2019 drew mixed reviews from pharma industry groups, who praised steps they say will improve access but warned the proposal does not properly address pricing or anticompetitive behavior. Read More
FDA Commissioner Scott Gottlieb issued a statement Tuesday highlighting what the agency would do with the increased funds provided in the administration’s proposed budget for FY 2019. Read More
The legislation would allow the NIH more flexibility to collaborate with companies developing innovative technologies aimed at addressing the opioid crisis. Read More
President Trump’s proposed budget for FY 2019 calls for a major increase in budget authority for the FDA along with a significant increase in user fees. Read More
Sponsors of drugs for treatment of bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer should use complete response rates in carcinoma in situ patients as their primary endpoint, the FDA said in a final guidance that is not significantly different from the agency’s 2016 draft. Read More
The FDA declined to approve a Pharmaceutical Manufacturing Research Services NDA for a new oxycodone hydrochloride product due to insufficient evidence of its abuse-deterrent properties, the agency said a Feb. 12 notice. Read More
Purdue Pharmaceuticals announced that it will no longer promote its opioid products to doctors and will cut its sales force by more than half. Read More