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Medtech petitioned the FDA to allow the company to submit an ANDA for generic Excedrin in which the proposed product is in a dosage form different from the reference drug. Read More
In his first appearance as HHS Secretary on Capitol Hill, Alex Azar fielded questions Wednesday about the Trump administration’s plans to address the opioid crisis and drug prices. Read More
“This policy helps restore the appropriate role of guidance documents and avoids rulemaking by enforcement,” said Associate Attorney General Rachel Brand. Read More
Leading U.S. opioid manufacturers donated millions of dollars to organizations that doubled as advocacy groups, potentially fueling the opioid epidemic, according to the latest report to emerge from the opioids investigation by Sen. Claire McCaskill (D-Mo.). Read More
Two senators called on the Trump administration to back a bill requiring drugmakers to justify any proposed price increases — invoking the president’s commitment in the State of the Union address to prioritize reducing drug prices. Read More
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
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