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  • Regulatory NewsRegulatory News

    CDER Goals for 2017: Improved Informatics, Cures Act Implementation and User Fees

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock outlined the critical priorities for 2017 in a new podcast as part of what she said will be "another busy and productive year." On the informatics front, Woodcock said that last summer, the executive committee of the FDA had a retreat and "the number one item there was improving and really implementing Informatics Process Management and so forth across the w...
  • Regulatory NewsRegulatory News

    Vermont Governor Signs Bill With Possible $10K Fines for Drug Price Hikes

    Vermont Gov. Peter Shumlin (D) on Friday signed into law a bill that would highlight drugs that the state spends significant amounts of money on, and companies owning those drugs could be hit with up to $10,000 in penalties if the wholesale acquisition costs rise too quickly and they fail to disclose the reasons for such hikes. Shumlin said Friday the bill was directed at providing answers on why pharmaceutical companies, like Turing Pharmaceuticals, disproportionately h...
  • Regulatory NewsRegulatory News

    Senate Committee Advances Five More Bills as Part of Medical Innovation Package

    The Senate Health, Education, Labor & Pensions Committee on Wednesday advanced five more bills to the Senate floor for discussion as part of a series of 19 companion bills to the mammoth House-passed 21st Century Cures bill. Wednesday marked the third and final hearing by the committee, which is still grappling with a fight over $50 billion in additional mandatory funding for the National Institutes of Health (NIH) that’s supported by Senate Democrats. “With its 21st C...
  • Regulatory NewsRegulatory News

    Senate Committee Advances Seven Bills Linked to Drug, Device Regulations and Research

    The Senate Health, Education Labor & Pensions Committee (HELP) on Tuesday advanced seven bills that could serve as piecemeal counterparts to House-passed Cures legislation from last year. The swath of new bills would, among other things, streamline the US Food and Drug Administration’s (FDA) review process for innovative medical devices, bolster FDA's oversight of reusable devices, accelerate the approval process for some “targeted” rare disease drugs and aid the Nationa...
  • Bills Strengthen Whistleblower Protections for Government, Private Sector Employees

    • 03 October 2012
    Two pieces of legislation introduced in the US House and Senate this past week aim to protect government and private sector whistleblowers who call attention to alleged wrongdoing. The first bill, the Whistleblower Protection Enhancement Act of 2012, would protect the release of certain information by government employees. "Federal employees and the American people must feel confident that those with the courage to come forward to disclose wrongdoing will be prote...
  • President Obama Signs into Law Three Bills Affecting FDA

    US President Barack Obama has signed into law three pieces of legislation that affect-directly or indirectly-the activities of the US Food and Drug Administration. User Fees Front and Center The first, and perhaps the most important, bill  was House Joint Resolution 117, the Continuing Appropriations Resolution of 2013 . The bill would maintain funding for US government agencies at fiscal year 2012 levels. While not specifically aimed at FDA, without the legis...
  • Report: Track and Trace Negotiations Resume in Congress

    • 10 August 2012
    Track-and-trace is dead; long live track-and-trace. Politico reports staff members associated with the House Energy and Commerce (E&C) Subcommittee on Health and the Senate Health, Education, Labor and Pensions (HELP) Committee are meeting over the August congressional recess to restart stalled negotiations over pharmaceutical track-and-trace provisions. Track-and-trace refers to a system by which regulators and pharmaceutical companies can track the movement of...
  • Report: Track and Trace Provisions Removed from User Fee Bill

    • 18 June 2012
    Provisions aimed at establishing a system in which drug products would be given unique identifying numbers-a so-called ' track and trace ' system-has been removed from a draft user fee bill intended to fund the US Food and Drug Administration, reports Politico . Negotiators, currently attempting to resolve differences between the House and Senate versions of the user fee bill, have reportedly reached an impasse in their attempt to get track and trace provisions into the...
  • Legislators: To Help Alleviate Drug Shortages, Establish Track and Trace Provisions

    • 13 June 2012
    Two Democratic legislators this week sent a letter to members of the Senate's and House of Representatives' healthcare oversight committees detailing the findings of the legislators' investigation into the effects of the so-called "gray market" on prescription drug shortages. In their 11 June letter, Senator Jay Rockefeller (D-WV) and Representative Elijah Cummings (D-MD) said their investigation had "identified significant risks in the US pharmaceutical distribution cha...