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  • Regulatory NewsRegulatory News

    FDA Delays Implementing Parts of 'Intended Use' Rule

    Confusion and concerns over portions of a tobacco-related final rule have pushed the US Food and Drug Administration (FDA) to delay indefinitely the implementation of the sections dealing with the types of evidence FDA may consider to determine how a manufacturer intends for its medical product to be used. "This is a determination that can have significant implications for, among other things, how manufacturers communicate about and promote their products. How we determi...
  • Regulatory NewsRegulatory News

    House Bill Seeks to Expand Off-Label ‘Scientific Exchange’ Between Industry, Doctors

    While the US Food and Drug Administration (FDA) attempts to re-work its policy on off-label use communications, Rep. Morgan Griffith (R-VA) has introduced a new bill that would further allow pharmaceutical companies to discuss such uses with physicians. GOP representatives have criticized FDA recently for failing to update its policies on off-label use communications as the agency has lost several recent court cases on the issue , and has questioned the need for loos...
  • Regulatory NewsRegulatory News

    FDA Delays Final Rule on Intended Uses

    The US Food and Drug Administration (FDA) on Friday announced it will delay implementation of its final rule clarifying when tobacco products are regulated as medical products until March 2018 in response to a petition from biopharmaceutical industry groups that raised questions about how the rule would alter the agency's definition of intended uses for drugs and medical devices. The petition, filed by on behalf the Medical Information Working Group (MIWG), the Pharmaceu...
  • Regulatory NewsRegulatory News

    Industry Groups Petition FDA Over Revisions to ‘Intended Use’ Rule

    The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have petitioned the US Food and Drug Administration (FDA) following its “unexpected decision” last month to revise the definitions of “intended use” for drugs and medical devices. The industry groups call for this final rule to be stayed indefinitely and reconsidered because FDA failed to give fair no...
  • Regulatory NewsRegulatory News

    How an FDA Proposed Rule for Tobacco Products Could Have a Big Impact on 'Intended Uses' for Devices, Drugs

    Late last month, the US Food and Drug Administration (FDA) unveiled a new proposed rule that many in the pharmaceutical and medical device regulatory communities may have glanced over without a thought because it seemed to pertain only to tobacco products. But on a second look, the rule, if finalized, could have a major impact on the intended use regulations for drugs and devices. For both drugs and devices, an intended use is determined by a manufacturer's expressions, ...