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    EMA Staff Losses Tick Up as Workload Increases

    As the interim arrangements to allow European Medicines Agency (EMA) staff to telework from London have now ended, the agency said its total available workforce in Amsterdam is about 730, which is about 20% less than the 900 staffers EMA had in London. “Due to these ongoing resource constraints, delivery of EMA’s work programme for Q4 2019 will be challenging for the Agency, particularly in view of the need to implement new legislation for veterinary medicines and medic...
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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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    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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    RAPS AnnouncementsRAPS Announcements

    RAPS Opens Board of Directors Nominations

    Today, RAPS opened the call for nominations for three vacant positions on the 2020–22 term of its board of directors. RAPS is seeking qualified candidates to fill the roles of president-elect, treasurer and one director position. Nominations will be accepted now through 29 March. Nominees should be distinguished and experienced regulatory leaders with a strong desire to play an active role in advancing and supporting the profession. To be considered, candidates must be R...
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    RAPS 2019 Board of Directors Begins Term; Don Boyer Takes Helm as Chair

    RAPS welcomed its 2019 board of directors, which officially began its term on 1 January. Don Boyer, a former top Health Canada official who is now a private regulatory consultant, takes over as chairman.   “I am honored to serve as chairman of the RAPS board of directors,” said Boyer. “Throughout its history, RAPS has been instrumental in not only helping regulatory professionals do their jobs better, but also in driving awareness of the critical role the regulatory pr...
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    FDA Drafts PRV Guidance for Medical Countermeasures

    The US Food and Drug Administration (FDA) on Wednesday released new draft guidance to help companies understand how the agency will award priority review vouchers (PRVs) for qualifying medical products to diagnose, prevent or treat diseases or conditions associated with chemical, biological, radiological and nuclear (CBRN) threats and emerging infectious diseases. The draft, featuring 29 questions and answers on the new PRV program, is part of FDA’s implementation ...
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    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...
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    Barriers to FDA and CMS Parallel Reviews: Fear and Bandwidth, Shuren Says

    Medical device companies should want to streamline the process of getting their products reviewed simultaneously by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Centers for Medicare and Medicaid Services (CMS) - so why aren’t they? Jeff Shuren, director of CDRH late Monday told attendees of JP Morgan’s annual conference that he thinks fear and a limited amount of CMS staff are two reasons that the parallel review ...
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    FDA Targets Multiple Review Cycles With New Draft Guidance, MAPP

    Fresh out of a record year for generic drug approvals, the US Food and Drug Administration (FDA) on Wednesday kicked off the new year by releasing new draft guidance and a new manual of policies and procedures (MAPP) with an eye toward decreasing the number of review cycles abbreviated new drug applications (ANDAs) undergo before approval. Multiple review cycles has been an outstanding challenge for the agency in years past, with less than 10% of ANDAs winning ap...
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    Have PRVs Incentivized New Rare or Neglected Disease Research? Experts Discuss

    The priority review voucher (PRV) programs, created by Congress with an eye to incentivizing the development of new rare pediatric and neglected tropical disease drugs, have so far rewarded a wide range of small and large biopharma companies and products, though whether PRVs have actually spurred new research remains a question. Andrew Robertson, head of regulatory science and policy at Sanofi, and Rachel Cohen, regional executive director for the Drugs for Neglect...
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    FDA, CMS: Second Parallel Review Decision Ever for NGS Test

    The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and coverage decisions for Foundation Medicine's FoundationOne CDx next generation sequencing (NGS) based test. The test was reviewed under FDA and CMS' parallel review program, and is only the second test to be approved and cleared under the program since its inception in 2011, the first being Exact Sciences' Cologuard colorectal cance...
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    As Transparency on Priority Review Vouchers Fades, Prices Level Off

    In the early days of the priority review voucher (PRV) programs, back in 2014 and 2015, companies publicly disclosed who they sold their PRVs to, how much they cost and which products they were eventually used to speed the review of. But now that 17 PRVs have been issued by the US Food and Drug Administration (FDA), news of PRV sales has slowed to a trickle of SEC filings and the rare press release. Three times already in 2017, with GlaxoSmithKline and Teva’s...