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  • RoundupsRoundups

    Euro Roundup: Commission seeks 5-year extension MDR/IVDR delegated acts powers

    The European Commission is seeking a five-year extension of the power to adopt delegated acts related to the new medical device and in vitro diagnostic regulations (MDR/IVDR). Officials said that an extension is needed because flexibility will be required as science advances and experience of the rules increases.   When the two regulations entered into force in 2017, the Commission gained the power to adopt several delegated acts. The power was scheduled to last for fi...
  • ReconRecon

    Recon: Moderna requests vaccine EUA for children under 6; Pfizer to begin US trial of Duchenne gene therapy as FDA lifts hold

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna files for US authorization of COVID shot for kids under 6 ( Reuters ) ( Endpoints ) ( Biospace ) Pfizer can restart PhIII trial of Duchenne gene therapy, now on par for late-2023 FDA approval request  ( Endpoints ) ( Reuters ) ( Fierce ) ( BioSpace ) IRS seeks more than $7B in back taxes and penalties from Amgen for shifting profits to Puerto Rico ( End...
  • Regulatory NewsRegulatory News

    MDCG issues guidance to help define ‘borderline’ products

    Developers struggling to decide whether their products are drugs or devices now have clearer definitions thanks to new guidance issued by the European Commission’s Medical Device Coordination Group (MDCG).   In general, determining whether a product is a device covered by the Medical Devices Regulation 2017/745 or a medicine covered by Directive 2001/83/EC on the Community code relating to medicinal products for human use (MPD) is straightforward.   For other pro...
  • Regulatory NewsRegulatory News

    FDA official discusses common deficiencies derailing ANDAs

    The US Food and Drug Administration (FDA) rejected a fewer number of abbreviated new drug applications (ANDAs) in FY 2021 through its refuse-to-receive (RTR) mechanism compared to previous years, said Peter Enos, a reviewer with the agency’s Office of Generic Drugs. He attributed the improvement to increased transparency with industry, better filing practices and enhanced communication with applicants.   Enos also addressed how industry can improve their submissions to...
  • Regulatory NewsRegulatory News

    FDA finalizes electronic postmarketing safety reporting guidance

    The US Food and Drug Administration (FDA) has finalized guidance that outlines how postmarketing safety reports for drugs and biologics should be submitted electronically. The guidance follows a final rule and corresponding draft guidance issued by the agency in 2014 to streamline the safety reporting process.   On 27 April FDA published the Providing Submissions in Electronic Format—Postmarketing Safety Reports final guidance. The draft version was published in 20...
  • Regulatory NewsRegulatory News

    European Commission outlines preparedness plan for COVID-19 management, future pandemics

    With COVID-19 infections now leading to fewer hospitalizations and deaths compared with earlier phases of the pandemic, the European Union (EU) and its Member States should take the opportunity to shift to a more sustainable management of COVID-19, with an eye towards preparing for future pandemics, according to a recent communication released by the European Commission (EC).   While the communication emphasized that the COVID-19 pandemic is not over—noting there are s...
  • ReconRecon

    Recon: Pfizer, BioNTech request booster EUA for children 5-11; Novartis confirms layoffs as part of global reorg

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Fauci: US no longer in ‘full-blown’ pandemic phase ( Washington Post ) Pfizer, BioNTech seek US authorization of COVID-19 booster shot for younger kids ( Reuters ) ( NPR ) Zolgensma for dementia? AviadoBio gains orphan tag for one-dose gene therapy ( Fierce ) Fennec looks for FDA approval for hearing loss drug haunted by manufacturing problems ( Endpoints ) E...
  • Regulatory NewsRegulatory News

    Burr chastises FDA at second Senate user fee hearing

    Sen. Richard Burr (R-NC) continued to criticize the US Food and Drug Administration (FDA) for failing to provide lawmakers a Medical Device User Fee Amendments (MDUFA V) deal and for not publishing meeting minutes with industry on time. His comments came during the second user fee reauthorization hearing in the Senate Health, Education, Labor and Pensions (HELP) committee.   On 26 April, the directors of FDA’s medical product centers sat before the HELP committee to ...
  • Regulatory NewsRegulatory News

    Medtech remanufacturing is the new battleground for right-to-repair advocates

    Medical device remanufacturing is the new front in the right-to-repair fight according to advocates who want users to have the ability to fix their own devices rather than rely on the manufacturer. While advocates continue to lobby for legislation locally and nationally on the issue, they warn that medtech industry groups are trying to find other ways to limit the ability of individuals and third-parties to repair devices.   When US lawmakers proposed draft legislation...
  • Regulatory NewsRegulatory News

    FDA officials: Firms with strong quality cultures more resilient to data integrity problems

    US Food and Drug Administration (FDA) officials asserted at a 26 April Generic Drug Forum (GDF) that firms with weak quality cultures are more susceptible to submit abbreviated new drug applications (ANDA) with data integrity problems than companies with stronger culture. Yet officials continue to see data integrity problems across the board, affecting all elements of ANDA submissions.   At the forum, which was sponsored by FDA’s Small Business and Industry Assistanc...
  • RoundupsRoundups

    Asia-Pacific Roundup: Philippine FDA seeks input on easing maximum retail price labeling process

    The Philippine Food and Drug Administration (FDA) is seeking feedback on draft guidelines intended to streamline the process for changing labels on drug products covered by maximum retail prices (MRPs).   In recent years, the Philippines has established and expanded a list of medicines that are covered by MRPs to ensure access to affordable, quality drug products. The government added a further 34 drug molecules and 71 drug formulas to the list of hundreds of medicines...
  • ReconRecon

    Recon: FDA approves Gilead’s Veklury for young children; Nektar to lay off 70% of its staff after key drug failure

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to widen COVID antiviral pill distribution ( Reuters ) ( STAT ) US FDA approves Gilead's COVID-19 drug for young children ( Reuters ) ( FDA ) Nektar to cut over 500 jobs following cancer drug failure ( Reuters ) Right to try 2.0: Advocates want to reduce oversight of ‘n of 1’ therapies ( STAT ) Experts fear US may default to annual Covid boosters without s...