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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...
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    Grassley Calls for More Unannounced Foreign Drug Inspections From FDA

    As the US Food and Drug Administration (FDA) explores plans to lower the cost of pharmaceuticals with imports from Canada and elsewhere, Sen. Chuck Grassley (R-IA) is calling on the agency to perform more unannounced inspections of foreign facilities. Thanks to recent media coverage (on  China and tainted blood pressure medicines  and another article on  generic drug manufacturing ) as well as a controversial new book on the US reliance on foreign-made generic medicin...
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    Q&A: Why Seven Regulators Use One Company’s Software for Drug and Biologics Reviews

    To streamline decision-making in approval processes, three regulatory authorities joined four others Thursday in increasing their adoption of drug development consultancy Certara’s Phoenix platform. The UK’s Medicines and Healthcare products Agency (MHRA), Brazil’s National Health Surveillance Agency (ANVISA) and Japan’s Pharmaceuticals and Medical Device Agency (PMDA) are now licensing Certara’s Phoenix IVIVC toolkit for in vitro-in vivo correlation. The agencies wer...
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    House E&C Committee Addresses 7 Bills to Improve Generic Competition

    The House Committee on Energy & Commerce’s health subcommittee on Wednesday held a hearing to discuss seven bills that help generic drug companies gain access to samples for testing necessary to win generic approval, tweak parts of the 180-day exclusivity that first generic filers can win and make updates to the Orange Book of generic drug patents and the Purple Book for biosimilars. All seven bills are part of Congress’ attempt to bring more generic drug competition to...
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    2018 in Generic Drugs: Approvals Shine but Questions Remain on Competition

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) this week released its year in review, highlighting another banner year for approvals and new guidance documents. 2018 was the first year of GDUFA II, during which FDA implemented certain new provisions tied to the program and the FDA Reauthorization Act of 2017 (FDARA), including pre-ANDA meetings, reconsideration requests, one-time marketing status updates to the Orange Book and competitive gen...
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    Generic Drugs: FDA Releases 74 Product-Specific Guidances

    As part of its push to increase generic competition, the US Food and Drug Administration (FDA) on Friday published 74 product-specific guidances, including 22 new and 52 revised guidances.   Four of the new draft guidances and 45 of the revised guidances are for complex drug products, including 16 products for which there are currently no approved abbreviated new drug applications (ANDAs).   Among the new product-specific guidances is help for companies looking to ...
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    FDA Defends its Efforts to Ensure Generic Drug Quality

    The US Food and Drug Administration (FDA) on Friday sought to quell a series of media reports raising questions with the agency’s declining inspectional work around the globe and concerns with the agency’s oversight of generic drugs. FDA Commissioner Scott Gottlieb and FDA’s Center for Drug Evaluation and Research Director Janet Woodcock wrote in an extended statement that recent press reports inaccurately raised questions with the quality of the US drug supply and wron...
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    Industry, Advocacy Groups Seek Clarity on Proposed Changes to Informed Consent Rules

    Trade associations representing the medical device and clinical research industries, as well as the nonprofit public advocacy organization Public Citizen, are calling for the US Food and Drug Administration (FDA) to clarify provisions of its proposed rule for institutional review boards (IRBs) to waive or alter requirements for obtaining informed consent for certain clinical trials involving minimal risk to participants.   Background   Under current FDA regulations...
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    FDA Updates List of Brand Name Companies Blocking Generic Applicants

    Back in November 2017, FDA Commissioner Scott Gottlieb called on brand name drug companies to “end the shenanigans” around delaying or restricting generic drug competition. But that call to action has not stopped brand name companies from continuing to pursue at least one gaming tactic, which is refusing to provide samples to competitors looking to bring generic products to market. As part of an effort to deter such a tactic, FDA recently created and updated a list o...
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    Marketing Status Notifications: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Wednesday unveiled new draft guidance to help sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) understand what information they’re now required to share with FDA on the marketing status of their brand and generic drugs. Thanks to the FDA Reauthorization Act of 2017 , drugmakers are required to provide additional information regarding the marketing status of approved drug products, includ...
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    European Commission Focuses New Report on Pharma Competition Enforcement

    The European Commission (EC) on Monday released a report on pharmaceutical competition enforcement activities by the Commission and EU member states' national competition authorities from 2009 to 2017.   The 46-page report was put together in response to concerns voiced by the European Council and Parliament in 2016 and 2017 regarding anticompetitive practices within the pharmaceutical sector, such as tactics to delay generic competition, pay-for-delay arrangements...
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    Industry Calls for Metrics on CDRH’s Breakthrough Device Program

    A consensus of industry participants at a US Food and Drug Administration (FDA) webinar on Thursday pressed for metrics on the medical device priority review program run by FDA’s Center for Devices and Radiological Health (CDRH). The webinar led by Maureen Dreher, policy analyst at CDRH’s Office of Device Evaluation, underscored the need for additional transparency around the Breakthrough Device Program. This request was supported across several participants during the ...