• Regulatory NewsRegulatory News

    Expert proposes changes to accelerated approval reforms in user fee bills

    With the Senate Committee on Health, Education, Labor and Pensions (HELP) recently releasing the Food and Drug Administration Safety and Landmark Advancements (FDASLA) act from committee, some stakeholders are proposing Congress make changes to the user fee authorization bill to address issues with the US Food and Drug Administration’s (FDA) accelerated approval pathway.   While some of the accelerated approval reforms in the House and Senate user fee billl are simil...
  • Regulatory NewsRegulatory News

    FDA considers pilot for lower radiation levels for device sterilization

    The US Food and Drug Administration (FDA) may allow medical device manufacturers to modify their radiation sterilization processes to prevent supply shortages. The agency is considering a pilot program to allow lower radiation levels for sterilization for premarket approved (PMA) products, though it would not apply to 510(k) devices. The pilot would include gamma radiation sterilization.   On 7 June, FDA said it was considering a master file pilot program for PMA dev...
  • ReconRecon

    Recon: Moderna touts Omicron-targeted bivalent vaccine; EMA lists critical medicines against COVID-19

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna says Omicron-targeted COVID shot shows better response ( Reuters ) ( NYTimes ) ( STAT ) ( Moderna ) Breast Cancer Drug Trial Results in ‘Unheard-Of’ Survival ( NYTimes ) Novavax COVID shot, aimed at vaccine skeptics, overwhelmingly backed by FDA panel ( Reuters ) ( STAT ) Sanofi's Dupixent gets U.S. approval to treat eczema in young children ( Reuters ...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    RAPS congratulates 108 spring RAC exam passers

    RAPS today announced that 108 professionals passed the Regulatory Affairs Certification (RAC) exams in the spring examination window, which occurred in March and April 2022. In doing so, these professionals have obtained their RAC-Drugs or RAC-Devices designation, the leading credentials for regulatory professionals in the healthcare product sector. These 108 individuals join more than 5,000 global professionals who hold RAC certifications. “On behalf of RAPS, I offe...
  • Regulatory NewsRegulatory News

    FDA’s OPDP takes Althera to task over cholesterol drug promotion

    The US Food and Drug Administration (FDA) has admonished Althera Pharmaceuticals for misrepresenting the efficacy and risk profile of its cholesterol-lowering drug Roszet (rosuvastatin and ezetimibe) in promotional materials. The agency said the company used a faulty analysis to show the drug’s effectiveness and underplayed its risks.   On 7 June, FDA’s Office of Prescription Drug Promotion (OPDP) published an untitled letter to Althera dated 2 June that raised conce...
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    Cavazzoni: Pandemic-era tools, learnings are here to stay

    The US Food and Drug Administration’s (FDA) top drug official said the pandemic has prompted the agency to consider new ways of working going forward and has renewed calls for industry to embrace digital technologies and decentralized models for conducting clinical trials. The pandemic has also prompted the agency to re-evaluate its hiring practices, and to adopt the use of alternative tools in lieu of onsite inspections, which have become a permanent fixture in the agency...
  • ReconRecon

    Recon: FDA staff indicates support for Bluebird gene therapy; FDA expert panel reviews Novavax vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Bluebird bio's blood disorder therapy effective - FDA staff ( Reuters ) ( Endpoints ) FDA expert panel weighs Novavax COVID vaccine ( Reuters ) ( WSJ ) FDA advisers recommend authorization of Novavax’s Covid-19 vaccine ( STAT ) Former Lilly manager files whistleblower lawsuit over manufacturing failures at production plant ( STAT ) ( Fierce ) Seres Therapeuti...
  • RoundupsRoundups

    Asia-Pacific Roundup: Philippine FDA consults on accelerated registration of WHO-prequalified products

    The Philippine Food and Drug Administration (FDA) is holding a consultation on its draft implementing guidelines on the collaborative procedure for the accelerated registration of World Health Organization (WHO)-prequalified pharmaceutical products and vaccines.   WHO issued a collaborative review procedure in 2013, and updated the text in 2016, to enable national regulatory agencies to leverage its scientific assessments to enhance their premarketing evaluation and re...
  • Regulatory NewsRegulatory News

    FDA adds transition period to electromagnetic compatibility final guidance

    The US Food and Drug Administration (FDA) has finalized guidance on medical device electromagnetic compatibility that replaces a 2016 document on the same topic. While the agency is giving medical device sponsors 60 days to adopt the guidance, in vitro diagnostic (IVD) makers will have a year to conform to it.   FDA finalized its Electromagnetic Compatibility (EMC) of Medical Devices guidance last week, after releasing the draft version for comment in November 2020...
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    PIC/S resuming onsite and desktop assessments this year

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced plans to restart assessments for countries applying for membership, though it said these audits will be subject to available resources and other priorities. Such assessments will be conducted either onsite or though desktop assessments.   These plans were shared in the PIC/S 2022 work plan , which discusses the organization’s planned activities through the end of the year or in 2023, including upcomin...
  • ReconRecon

    Recon: FDA gives thumbs-up to GSK measles vaccine; FDA committee set to review Novavax COVID vaccine EUA on Tuesday

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US GSK measles vaccine gets FDA approval ( Reuters ) ( Endpoints ) ( Biospace ) FDA scientists say Novavax’s Covid-19 vaccine is effective, but also raise concerns ( STAT ) ( Endpoints ) ( InsideHealthPolicy ) Bristol Myers pulls plug on Reblozyl program for rare blood disorder, months after missed PDUFA date ( Endpoints ) 21 Americans Infected With Monkeypox, CD...
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    This Week at FDAThis Week at FDA

    This Week at FDA: Senate user fee markup, Novavax briefing docs, and CDRH withdraws a PHE guidance

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, we learned that the Senate Health, Education, Labor & Pensions (HELP) committee will markup its version of the FDA user fee reauthorization bill next week. We also got a glimpse at the briefing documents for FDA’s upcoming advisory committee meeting to review Novavax’s COVID-19...