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  • Regulatory NewsRegulatory News

    FDA Proposes Rule for Appealing CDRH Decisions

    The US Food and Drug Administration (FDA) on Tuesday proposed a new rule for appealing certain decisions about medical devices made by the Center for Devices and Radiological Health (CDRH). The proposed rule is in line with legislative requirements established by the Food and Drug Administration Safety and Innovation Act(FDASIA) and 21st Century Cures Act (Cures) for clarifying procedures and timeframes for appeals of "significant decisions" to CDRH. Section 517A of...
  • Regulatory NewsRegulatory News

    Significant Safety Events Found in a Third of FDA-Approved Drugs, Study Finds

    Among 222 novel therapeutics approved by the US Food and Drug Administration (FDA) from 2001 through 2010, 32% were affected by a postmarket safety event, according to a study published in JAMA on Tuesday. Biologics, psychiatric therapeutics and those receiving accelerated approval and near–regulatory deadline approval were statistically significantly associated with higher rates of events, the study found. Of the 222 new drugs and biologics assessed, the study f...
  • Proposed Bill Subject Some Regulations to Vote by Legislators

    A bill proposed by Rep. Tom Latham (R-IA) would seek to subject "significant regulations" to an up-or-down roll call vote by both the House of Representatives and the Senate. "Washington has buried hardworking American small business owners under a mountain of regulations and mandates, crushing their ability to grow, invest in our communities and create jobs," Latham said. "My legislation will bring accountability into the regulatory process and dispel the uncertainty pl...
  • Bill Would Freeze Major Regulatory Actions Until Unemployment Rate Falls

    • 27 February 2012
    A bill introduced in the US House of Representatives 17 February aims to halt the passage of any regulations that have economic costs of more than $100 million until the unemployment rate falls below 6%. The Regulatory Freeze for Jobs Act of 2012 (HR 4078) would also prevent any regulatory actions that creates inconsistencies with another agency, "raise novel legal or policy issues", or "materially alter the budgetary impact of entitlement, grants, user fees or loa...