• RoundupsRoundups

    Euro Roundup: MHRA contemplates a new regulatory framework for personalized medicines

    MHRA seeks feedback on making personalized medicines at the point of care   The UK Medicines and Healthcare products Regulatory Agency (MHRA) seeking input on whether the production of personalized medicines at the point of care (POC) is sufficiently different from standard manufacturing to require the creation of a new framework.   In contrast to traditional medicine manufacturing, where fewer facilities, working at scale, manufacture products for global distrib...
  • Regulatory NewsRegulatory News

    FDA affirms increased risk with pelvic mesh products

    The US Food and Drug Administration (FDA) announced on Monday that its review of final results from postmarket surveillance of transvaginal mesh devices meant to treat pelvic organ prolapse (POP) found that patients who received mesh repair had increased risk of mesh exposure and tissue erosion compared to patients whose prolapse was repaired with native tissue.   “Therefore, the FDA continues to believe that these devices do not have a favorable benefit-risk profile,”...
  • Regulatory NewsRegulatory News

    ICMRA: Address artificial intelligence challenges with permanent working group

    The rapid expansion and evolution of artificial intelligence (AI) will challenge the current regulatory pharmaceutical and device, according to a new horizon-scanning report from an international consortium of regulators. The ad hoc group recommends a permanent working group to stay abreast of the regulation of AI in the development and assessment of medicinal products.   A 6 August report from the International Coalition of Medicines Regulatory Authorities (ICMRA) d...
  • Feature ArticlesFeature Articles

    An overview of recent FDA activity on materials in medical devices

    In this article, the authors provide an overview of recent US Food and Drug Administration (FDA) interest and activity relating to the materials in implants regulated as medical devices. Since 2019, the increase in public and regulatory scrutiny of medical implants has resulted in an FDA advisory committee meeting, revised corrosion testing guidance, and proposed new labeling disclosures.   Introduction Medical devices offer innovative ways of treating various cond...
  • Feature ArticlesFeature Articles

    The SaMD regulatory landscape in the US and Europe

    The advent of artificial intelligence (AI) in the healthcare industry has resulted in a proliferation of novel health technologies with intuitive features. However, the regulatory landscape for such innovative products has yet to be fully understood. The US Food and Drug Administration (FDA) published a discussion paper on AI- and machine learning (ML)‒based software as a medical device (SaMD) in April 2019, which led to the release of an action plan that incorporated stak...
  • Regulatory NewsRegulatory News

    FDA's FY2022 Senate funding bill clears Appropriations committee

    The Senate Appropriations committee has completed its markup of the FY2022 budget for the US Food and Drug Administration (FDA), advancing by a 25-5 vote a bill that would hold the agency to a $200 million increase in its budget authority.   The bill exited the Appropriations subcommittee responsible for FDA funding on Monday with no objections to the Senate’s proposed 6% increase for the agency over FY2021 figures. (RELATED: Senate subcommittee advances FY2022 FDA f...
  • Regulatory NewsRegulatory News

    Notified bodies report success — and some drawbacks — using remote audits

    Remote audits conducted by notified bodies have been successful in ensuring that medical device manufacturers are complying with the EU’s Medical Device Regulation and In Vitro Diagnostics Regulation, according to a recently conducted survey  of 46 notified bodies, with remote audits uncovering roughly the same number of deficiencies as onsite audits.   The survey was conducted by the European Association of Medical Device Notified Bodies (TEAM NB), located in Liège...
  • Regulatory NewsRegulatory News

    EFPIA, others question EC's proposed orphan and pediatric drug development updates

    An initiative by the European Commission (EC) to boost the development of pediatric drugs and medicines for people with rare diseases has received stakeholder feedback that in many cases expresses concern with the proposed upending of the status quo.   A 60-day period of public consultation for the initiative’s roadmap closed at the end of July; in all, 112 comments were received from individuals, non-governmental organizations (NGOs), public authorities, medical socie...
  • Regulatory NewsRegulatory News

    Review: FDA device approval pathways more complex than ever

    The regulation of medical devices in the US has grown increasingly complex, with multiple pathways to gain marketplace entry and a shift toward collecting evidence in the postmarket setting.   The findings come from a sweeping study of more than 40 years of medical device regulation by the US Food and Drug Administration (FDA), beginning with the Medical Device Amendments of 1976, which first provided the agency with premarket review authority for devices. The analysis...
  • Regulatory NewsRegulatory News

    CTIS set to launch in EU; sponsor guide now online

    The European Commission (EC) has affirmed that it plans to launch the Clinical Trials Information System by the end of January 2022, as part of its broader efforts to modernize and streamline the conduct and oversight of clinical trials in the EU.   “The pandemic has clearly shown the importance of efficient clinical trials that do not compromise on rigorous safety and efficacy standards,” said Stella Kyriakides, EC commissioner for health and food safety, speaking o...
  • Regulatory NewsRegulatory News

    FTC to focus enforcement action on illegal repair restrictions

    In a unanimous vote, the Federal Trade Commission (FTC) has decided to focus law enforcement efforts on repair restrictions that impede or prevent consumers and businesses from repairing products they own.   “While unlawful repair restrictions have generally not been an enforcement priority for the Commission for a number of years, the Commission has determined that it will devote more enforcement resources to combat these practices,” FTC said in a new policy statemen...
  • ReconRecon

    RECON: FDA halts Pepaxto trials; Pfizer nears $8B in vax sales for Q2

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer sells $7.8 billion in Covid shots in the second quarter, raises 2021 guidance on vaccine sales ( CNBC ) AstraZeneca castoff draws $123M wager on CXCR2 antagonist as Arena lines up a buyout option ( Endpoints ) Opinion: US FDA Should Take Its Time With COVID Vaccine BLAs ( Pink Sheet ) Biden Is Considering A Vaccine Or Testing Mandate For Federal Workers...