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  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Convenience Kit UDI Marking

    The US Food and Drug Administration (FDA) issued final guidance Thursday to provide medical device manufacturers clarifications on unique device identification (UDI) marking policies for convenience kits. The guidance finalized the 2016 draft version of the document, developed by FDA’s Center for Devices and Radiological Health and its Center for Biologics Evaluation and Research. Combination products and in vitro diagnostics subject to labeling requirements fall ou...
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    FDA Finalizes Accelerated Approval Labeling Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on labeling drugs and biologics approved under the accelerated approval pathway.   FDA's accelerated approval program allows the agency to approve products to treat serious or life-threatening conditions based on surrogate or intermediate clinical endpoints "that are reasonably likely to predict clinical benefit." When granting accelerated approval, FDA will require a sponsor to complete postmarket...
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    Trial Transparency: NIH Says Final Rule From 2017 has Helped

    Almost a year ago, the National Institutes of Health (NIH) made effective a new policy to better disseminate information from NIH-funded clinical trials through ClinicalTrials.gov, and the agency says that so far, it’s seen some improvements. Back in 2007, section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) established a requirement that "applicable clinical trials" must be registered and information must be submitted to Clinicaltrials.gov. ...
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    FDA Bars Use of 24 Ingredients in Antiseptic Washes

    The US Food and Drug Administration (FDA) on Tuesday finalized a rule barring the use of 24 active ingredients, including triclosan, from use in over-the-counter (OTC) antiseptic washes and rubs such as hand washes and surgical hand scrubs used in health care settings. The rule was first proposed in 2015 , and finalizes a 1994 tentative final monograph for OTC antiseptics as amended by the 2015 proposed rule. "Ensuring the safety and effectiveness of over-the-counter h...
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    What's Coming in 2018: FDA's Regulatory Agenda

    The US Food and Drug Administration (FDA) published its fall 2017 agenda of proposed and final rulemakings this week, with several expected on drug compounding, allowing foreign clinical data to bring medical devices to market and new ways to market nonprescription drugs. On the compounding front, FDA plans to issue a proposed rule in August 2018 that would set minimum current good manufacturing practice requirements for human drug products compounded by an outso...
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    3D Printing: FDA Finalizes Guidance for Medical Devices

    The US Food and Drug Administration (FDA) on Monday finalized guidance on medical device additive manufacturing, also known as 3D printing. The guidance finalizes the draft version from May 2016 and largely keeps intact the recommendations and considerations laid out in the draft. FDA Commissioner Scott Gottlieb said Monday that the guidance "will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submis...
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    Drugged Driving: FDA Finalizes Study Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on how drugmakers should study the effects of their drugs on driving ability. The guidance is largely in line with the draft version issued in 2015, and continues to recommend that drugmakers follow the "tiered assessment" approach detailed in a 2011 report from the National Highway Traffic Safety Administration's Office of Behavioral Safety Research. FDA first introduced the draft guidance after ...
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    FDA Finalizes Combination Product Classification Guidance

    The US Food and Drug Administration (FDA) on Tuesday issued its final guidance on classifying combination products as drugs, biologics or medical devices. The guidance finalizes and combines two 2011 draft guidances, Classification of Products as Drugs and Devices & Additional Product Classification Issues and Interpretation of the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug and Cosmetic Act , and details how F...
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    FDA, HHS Finalize Guidance on Documenting IRB Activities

    The US Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) on Monday finalized a 2015 draft guidance on how to document institutional review board (IRB) activities. The guidance, developed jointly by the two agencies, details how and what IRBs should document in the meeting minutes they are required to keep under 45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2), which include: Attendance at the me...
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    CDRH Finalizes Guidance on Reporting Age, Race and Ethnicity Data in Studies

    • 12 September 2017
    The final guidance outlines FDA’s recommendations and expectations for patient enrollment, data analysis, and reporting of age, race and ethnicity data in medical device clinical studies. The agency said the specific objectives of the 36-page final guidance, first drafted in June 2016 , are to: (1) encourage the collection and consideration of age, race, ethnicity and associated covariates (e.g., body size, biomarkers and bone density) during a study’s design ...
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    FDA Finalizes Guidance on Deviation Reporting for HCT/Ps

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance to help manufacturers of non-reproductive human cells, tissues and cellular and tissue-based products (HCT/Ps) understand the agency’s recommendations and relevant examples for complying with the requirements to investigate and report HCT/P deviations. The 20-page guidance, first drafted in December 2015 , includes additional examples and editorial changes to improve clarity from the draft. ...
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    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...