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  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 25 February 2020 to include: Vifor Pharma said on 17 February that it p...
  • Regulatory NewsRegulatory News

    FDA Discusses Device Least Burdensome Provisions in New Draft Guidance

    After signaling that it would shift more of the regulatory oversight of medical devices to the postmarket setting, the US Food and Drug Administration (FDA) on Thursday issued a new draft guidance detailing updates to its least burdensome approach to regulating devices. FDA's least burdensome provisions were first introduced under the FDA Modernization Act (FDAMA) in 1997, and since then, both the FDA Safety and Innovation Act (FDASIA) and the 21st Century Cures Act...
  • Regulatory NewsRegulatory News

    Cures Act Implementation: Gottlieb Says Faster Cancer Drug Approvals Coming for Secondary Indications

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and NIH Director Francis Collins testified on Thursday before the House Energy & Commerce Committee on how their agencies have worked to implement provisions from the 21st Century Cures Act passed and signed by President Barack Obama a month before he left office. The hearing centered on the mammoth new law that includes major tweaks to how FDA regulates drugs, devices and biologics, and provides ...
  • Regulatory NewsRegulatory News

    FDA Singles Out Biologics Company for Failing to Meet Pediatric Study Requirement

    The US Food and Drug Administration (FDA) has determined that Organogenesis, Inc. has failed to meet the postmarketing requirement of the Pediatric Research Equity Act (PREA) for its Biologics License Application (BLA) for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT). FDA said in a letter sent to the company in late July that it has not yet submitted its pediatric assessment, which was identified in the BLA’s approval letter fro...
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    FDA Updates Guidance on Collecting Race, Ethnicity Data in Clinical Trials

    The US Food and Drug Administration (FDA) recently updated its 2005 guidance detailing its expectations sponsors for collecting race and ethnicity data in clinical trials for drugs, biologics and medical devices. According to the agency, the guidance has been updated to reflect a standardized approach to collecting race and ethnicity data in accordance with requirements under the 2010 Affordable Care Act (ACA) and the 2012 Food and Drug Administration Safety and Inn...
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    Pediatric Study Plans: FDA Unveils Revised Draft Guidance

    The US Food and Drug Administration (FDA) on Tuesday released updated draft guidance intended to help pharmaceutical sponsors submit pediatric study plans, including what should be included in the plans and how they should be submitted. This revision, which FDA says was based largely on public comments, includes additional clarifications on the 2013 draft guidance, such as new information on what constitutes a materially incomplete initial pediatric study plan (iPSP), th...
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    FDA Finalizes Six-Month Drug Shortage Notice Regulation

    A regulation proposed by the US Food and Drug Administration (FDA) in 2013 will take effect on 8 September, requiring drug and biologics manufacturers to notify the agency in advance of impending drug shortages. Background In 2011, after several years of worsening drug shortages, the Obama Administration issued Executive Order 13588 – Regarding Prescription Drug Shortages calling for measures to improve the response to drug shortages through stronger notification re...
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    Patient-Focused Drug Development Tracker

    Since the passage of the  Food and Drug Administration Safety and Innovation Act (FDASIA)  in 2012, the US Food and Drug Administration (FDA) has been publicly meeting with patients who suffer from debilitating conditions without adequate treatment options in the hopes of better understanding their wants and needs in the drug development process. Those meetings have raised novel questions for regulators, who for the first time are asking patients and patient groups to ex...
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    FDA Kicks off Reauthorization Process for PDUFA

    The US Food and Drug Administration (FDA) has announced the start of the next reauthorization process for the Prescription Drug User Fee Act (PDUFA), a major framework under which most new drug products in the US are reviewed. Background PDUFA was first authorized in 1992, and has since been reauthorized four times, most recently in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) . As with FDA's other user fee programs, PDUFA is based o...
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    FDA Substantially Increasing its Inspections of Foreign Generic Drug Companies

    The US Food and Drug Administration (FDA) has made substantial improvements to its inspections of foreign generic pharmaceutical manufacturers, a new report by the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) claims. Background OIG's report, issued on 4 May 2015, was prompted by congressional concerns that FDA lacked sufficient resources to inspect generic pharmaceutical manufacturers, which now make up nearly 80% of the prescript...
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    FDA Guidance Explains How Medical Device Companies Can Rely on Foreign Clinical Data

    New draft guidance issued by the US Food and Drug Administration (FDA) seeks to make it easier for medical device companies to rely on data obtained from clinical studies outside the US, provided those studies are conducted to appropriate federal standards. Background The draft guidance document, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States , is closely related to a rule proposed by FDA in February 2013. That rule, Hum...
  • Regulatory NewsRegulatory News

    Meeting With FDA? Here's What Regulators do (and Don't) Want from Drug Companies

    A new guidance document issued by the US Food and Drug Administration (FDA) is meant to outline the agency's expectations for meetings that take place between FDA and a sponsor before and after the submission of a new chemical or biological drug product. Background Since the passage of the original Prescription Drug User Fee Act (PDUFA) in 1992, the pharmaceutical and biopharmaceutical industries have helped to fund the operations of FDA through payments of so-called ...