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  • Regulatory NewsRegulatory News

    Senate Committee Advances FDA User Fee Reauthorization Bill

    The Senate Committee on Health, Education, Labor & Pensions on Thursday advanced by a vote of 21-2 a bill that would reauthorize the pharmaceutical, medical device, generic drug and biosimilar user fee agreements that expire at the end of September. Two additional amendments were added to the latest version of the bill , one from Sens. Orrin Hatch (R-UT), Michael Bennet (D-CO), Richard Burr (R-NC), and Bob Casey (D-PA) on expanded access to drugs and one from Sens...
  • Regulatory NewsRegulatory News

    Senate Democrats to Trump: Work With us to Lower Drug Prices

    Sens. Sherrod Brown (D-OH), Al Franken (D-MN) and 17 of their Democratic and Independent colleagues on Tuesday sent a letter to President-elect Donald Trump, urging him to combat the pharmaceutical industry’s “abusive tactics” that “price lifesaving drugs out of reach for those in need.” The senators lay out five actions to address the rise in pharmaceutical prices, including: Allowing the secretary of the Department of Health and Human Services to negotiate drug pric...
  • Senator: Regulators and Medical Device Manufacturers Must Find Common Ground

    Minnesota Senator Al Franken (D-MN) told media present at the Design of Medical Devices Conference he doesn't believe there needs be a choice between having medical devices be proven safe or having those devices be brought to market quickly, reports The Star Tribune . "To some degree, there is a false choice there," said Franken, a member of the Senate Health, Education, Labor and Pensions Committee which oversees the US Food and Drug Administration. The way forward, e...