• Regulatory NewsRegulatory News

    FDA should step in to help spur AI/ML standards: Expert

    The US Food and Drug Administration (FDA) should support the burgeoning integration of artificial intelligence and machine learning (AI/ML) in medical devices by encouraging the development of new standards and setting deadlines for their implementation.   That’s according to Brad Thompson, a regulatory attorney at Epstein, Becker and Green. Thompson spoke with Regulatory Focus on the state of AI/ML and what can be done to help move the regulatory needle forward. Whi...
  • Regulatory NewsRegulatory News

    All eyes on Senate after House passes user fee reauthorization bill

    The US House overwhelmingly passed its Food and Drug Administration (FDA) user fee reauthorization bill that has been delayed largely due to the COVID-19 pandemic. Now the ball is with the US Senate, which is expected to hold a postponed markup hearing next week on its version of the bill that includes several different provisions.   Unsurprisingly, the House voted 392-28 to approve the user fee reauthorization on 8 June after it had already been approved unanimously b...
  • 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...
  • 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...
  • 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...
  • Regulatory NewsRegulatory News
    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...
  • Regulatory NewsRegulatory News

    EU regulators offer new guidance on complex clinical trials

    European regulators published a question and answer document that they hope will give more clarity on how complex clinical trials (CCT) should be conducted. The document aims to answer some basic questions, such as what to consider in the planning and conduct of CCTs, how to justify Bayesian approaches to regulators, and how to use biomarkers.   On 2 June, the European Commission (EC), European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) publishe...
  • Regulatory NewsRegulatory News

    FDA withdraws cancer drug approval after finding possible higher death rates

    The US Food and Drug Administration has rescinded its approval of TG Therapeutics’ Ukoniq (umbralisib) after a clinical trial found patients on the cancer drug may have a higher mortality rate. The news comes a month and a half after the company voluntarily pulled the drug from market for the same reason. On 1 June, the FDA issued a safety communication that it was withdrawing approval of Ukoniq which had been approved to treat marginal zone lymphoma (MZL) and folli...
  • Regulatory NewsRegulatory News

    New diagnostics authorities, accelerated approval council featured in Senate user fee bill

    The Senate Health, Energy, Labor and Pensions (HELP) committee has introduced its version of the user fee reauthorization bill. Like its sister bill in the House, the proposed legislation would introduce new guardrails around the US Food and Drug Administration’s (FDA) accelerated approval program, though it includes notable departures from the House bill, such as new authorities for FDA to oversee certain diagnostic products.   On 27 May, the HELP committee published ...
  • Regulatory NewsRegulatory News
    This Week at FDAThis Week at FDA

    This Week at FDA: Upcoming VRBPAC meetings, Califf on the Hill and ARPA-H gets official

    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, FDA announced the dates for three upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings to review the Moderna and Pfizer/BioNTech vaccines for younger children, Novavax’s COVID-19 vaccine and SARS-CoV-2 strain composition for modified vaccines. ...
  • Regulatory NewsRegulatory News

    IVDR implementation day overshadowed by lack of notified bodies, risks to patients

    While the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) is now in effect, stakeholders are concerned that the road forward is not going to be easy, especially due to the lack of notified body capacity to handle the influx of conformity assessments necessitated by the new regulation.   On 26 May, medtech manufacturers, notified bodies and regulators woke up to a brave new world where IVDR is the law of the land. Under the regulation, new diagnos...
  • Regulatory NewsRegulatory News

    Euro Convergence: SSCP expert lists common mistakes device manufacturers make

    AMSTERDAM – Some of the most common mistakes manufacturers make when complying with safety and clinical performance (SSCP) requirements may sound simple enough to fix, but such issues tend to be persistent, said Rachel Gibbs, principal regulatory consultant at NAMSA, during this year’s RAPS Euro Convergence meeting in Amsterdam.   Beyond her current role at NAMSA, where she advises companies on how to comply with notified body requirements, Gibbs also has experience as...