• ReconRecon

    Recon: FDA vax approval signals looming mandates; Pfizer's $2.3B Trillium takeover

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer's COVID Vaccine Gets Full Approval From The FDA ( NPR ) ( NYT ) ( NBC ) Biden calls on companies to mandate vaccines following FDA full approval ( The Hill ) Pentagon set to make Pfizer vaccine mandatory after FDA approval ( Reuters ) New York City, The Country's Largest School System, Mandates Teacher Vaccinations ( NPR ) The U.S. Is Getting a Cra...
  • Regulatory NewsRegulatory News

    FDA refreshes bioequivalence guidance for generic drugs

    Generic drug makers received a refreshed draft guidance from the US Food and Drug Administration on Friday; the guidance updates some recommendations on the conduct of bioequivalence (BE) studies that have pharmacokinetic endpoints.   In announcing the updated draft guidance’s availability, FDA said that the document is meant to "clarify the agency’s recommendations regarding BE information submitted in an [abbreviated new drug application] submission, provide assistan...
  • Regulatory NewsRegulatory News

    FDA studies consumer perception of DTC drug ads, willingness to report false claims

    The US Food and Drug Administration (FDA) is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on how to measure consumer perceptions of the information presented in ads.   In a recent Regulatory Science in Action article , the agency outlined findings from three studies looking at the role of images in advertising, the development of valid measures to assess perception of ads, and the likelihood that physicians and consume...
  • Regulatory NewsRegulatory News

    Researchers: France could teach the US lessons in biosimilar pricing

    The US should look to the French healthcare system for lessons in reducing biosimilar pricing, according to a recent paper published in Health Affairs .   James C. Robinson, of the Division of Health Policy and Management, School of Public Health at the University of California Berkeley, and colleagues said the US “lacks consistent incentives for physicians to prescribe low-price biosimilars and for manufacturers to compete using price reductions” and that the slow up...
  • ReconRecon

    Recon: NYT says Abbott destroyed COVID tests when sales dwindled; Woodcock out of running for FDA commissioner?

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Maker of Popular Covid Test Told Factory to Destroy Inventory ( NYT ) Acting FDA Chief Janet Woodcock Ruled Out as Biden Nominee ( Bloomberg ) Child Covid-19 hospitalizations soar, filling pediatric wings, data show ( NBC ) White House: More than one million vaccine doses administered in past 24 hours ( The Hill ) Three senators announce positive COVID-19...
  • Regulatory NewsRegulatory News

    FDA report: Drug quality tops OPQ's list of product defects

    A new report from the US Food and Drug Administration's (FDA's) Office of Pharmaceutical Quality (OPQ) details the top drug quality issues seen in from 2016-2020, with questions of product quality topping the list.   In all, just over a quarter (27%) of all Product Quality Defect (PQD) reports were related to product quality issues, while device and packaging issues together made up another third of the PDQ reports over the 5-year period.   The PQD reports came fro...
  • Regulatory NewsRegulatory News

    Working group: More guidance needed on MRD in myeloma trials

    A working group formed to consider the use of minimal residual disease (MRD) in the treatment of multiple myeloma and the development of new therapies has issued a call for additional regulatory guidance on the use of MRD as a marker in clinical trials.   The working group, a collaboration of advocacy organizations, patients, research foundations, academic, government agencies and industry, was initially convened in 2016 by the Foundation for the National Institutes of...
  • RoundupsRoundups

    FDA Approvals Roundup: Jemperli, Welireg, Xywav

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Jemperli cleared for dMMR advanced solid tumors GlaxoSmithKline’s Jemperli (dostarlimab-gxly) has been granted accelerated approval for treating adults  with mismatch repair deficient (dMMR) recurrent or advanced solid tumors whose disease has progressed despite treatment.   The Ventana MMR RxDx Panel was also approved as a companion diagnos...
  • Regulatory NewsRegulatory News

    FDA, with academic and community partners, launches first pediatric ECG warehouse

    Pediatric electrocardiogram (ECG) data being collected by the US Food and Drug Administration are now available in a first-of-kind data warehouse.   The warehouse, a mirror of a similar data warehouse for adult ECG data, collects and makes available a rich store of information “to enhance cardiac safety review for therapeutic product development for children,” according to a new FDA Spotlight article announcing the launch of the warehouse.   One prong of the wo...
  • Regulatory NewsRegulatory News

    FDA-registered sites declined in 2020: OPQ drug quality report

    A new report from the US Food and Drug Administration's (FDA's) Office of Pharmaceutical Quality (OPQ) shows a small drop overall in drug manufacturing sites and a shift toward pandemic-related priorities in FY 2020.   The OPQ report on the state of pharmaceutical quality for FY 2020 notes that drug manufacturing sites included in FDA’s site catalog declined by just over 1% in FY 2020 to 4,221. Medical gas manufacturers are excluded from this figure, as are the crop ...
  • 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...