• Regulatory NewsRegulatory News

    IT and staffing issues impeded CDRH pandemic test response: Report

    Lagging information technology infrastructure, inefficient staffing, and validation methods that were not set up for a pandemic were among the weaknesses identified by an outside assessment of the U.S. Food and Drug Administration’s (FDA's) handling of COVID-19 diagnostic test emergency use authorizations (EUAs) during the pandemic.   The independent report, conducted by the consulting firm Booz Allen Hamilton at the request of FDA's Center for Devices and Radiological...
  • RoundupsRoundups

    FDA Approvals Roundup: Tavneos, Verzenio, Dextenza

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tavneos okayed for ANCA-associated vasculitis ChemoCentryx’s Tavneos (avacopan) has been approved as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis, also known as ANCA-associated vasculitis, in combination with standard therapy.   ANCA-associated vasculitis is a group of thr...
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    FDA warns companies for GMP violations, conducting trial without IND

    A contact testing laboratory found in violation of Current Good Manufacturing Practice (CGMP) regulations and a nutritional supplement company conducting a clinical investigation without an investigational new drug application (IND) have been sent warning letters by the US Food and Drug Administration (FDA).   FDA sent Missouri Analytical Laboratories Inc. a warning letter on 30 September due to “significant violations” of CGMP and “significant deviations from CGMP" fo...
  • ReconRecon

    Recon: FDA approves Lilly's Verzenio for early breast cancer; Ebola vaccination campaign begins in Congo

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Data suggests mRNA booster dose generates stronger antibody response after J&J shot – Axios ( Reuters ) Relying on J&J's analyses to assess vaccine booster dose data -U.S. FDA staff ( Reuters ) ( NYTimes ) US FDA staff says Moderna did not meet all criteria for COVID-19 boosters ( Reuters ) Vaccine requirements raised COVID-19 vaccination rates by 20 percentag...
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    ICMRA: Industry's commitment to quality can facilitate regulatory flexibility

    Frequent communication with industry and relying on assessments by other regulators have enabled the rapid scale-up of COVID-19 vaccines and therapeutics, asserted regulators and industry representatives attending a July workshop sponsored by the International Coalition of Medicines Regulatory Authorities (ICMRA).   The workshop explored how different regulatory tools are being deployed to increase manufacturing capacity for vaccines during the COVID-19 pandemic. The...
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    Asia-Pacific Roundup: TGA releases risk classification guidance for active medical devices

    TGA releases guide to classifying active medical devices by risk   New guidance from Australia’s Therapeutic Goods Administration (TGA) on the risk classification of active medical devices covers software-based products and other medical devices that act by converting energy. Examples of covered devices include pacemakers and phototherapy devices.   The EU defined the term “active medical device” in its Medical Device Regulation (MDR). TGA, which follows the EU w...
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    EMA's challenges through 2023: Global collaboration, supply shortages, antimicrobial resistance

    The European Medicines Agency (EMA) recently released its final programming document for 2021 to 2023, setting goals to address medicine availability and shortages, analysis and access to healthcare data, supply chain issues, and antimicrobial resistance.   Emer Cooke, EMA Executive Director, stated in the document’s foreword that much of the agency’s planning over the next few years will be accomplished by implementing the EMA Network Strategy and Regulatory Science S...
  • ReconRecon

    Recon: CureVac pulls back its COVID mRNA vax; Medtronic's new robotics bid

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency ( FDA ) FDA still without a permanent leader as clock ticks down on acting head ( CNN ) IPO floodgates open up after summer lull as five more biotechs file for Nasdaq ( Endpoints ) FDA staff doesn’t take stance on Moderna Covid booster shots, says two doses are...
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    New USP chapter details lifecycle approach to analytical testing

    The United States Pharmacopoeia (USP) has released a new chapter 1220 ahead of publication in the USP-NF that sets a lifecycle approach to analytical method development with the goal of easing the process for instituting post-approval changes for analytical methods. The chapter will become official on 1 May 2022.   The USP chapter complements efforts underway at International Council for Harmonisation to develop a Q14 guideline to make it easier for manufacturers t...
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    FDA official breaks down novel excipient pilot program

    A new pilot program from the US Food and Drug Administration (FDA) dedicated to reviewing quality and toxicology data for novel drug excipients is aimed at speeding drug development by providing an easier pathway for the agency to qualify these ingredients.   “In some cases, FDA may find issues with the excipients used in a drug development application, which can affect and even delay the application,” explained FDA official Karen Davis Bruno, associate director of pha...
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    FDA’s accelerated approval program: Is change on the way?

    The U.S. Food and Drug Administration (FDA) launched its accelerated approval program in 1992, offering a pathway to bring life-saving drugs and biologics to the market faster. After nearly 30 years, could substantial reforms be on the way?   At RAPS Convergence 2021, David Dorsey of Janssen R&D, said Congress could choose to make changes to the accelerated approval program through the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA). Congress has...
  • ReconRecon

    Recon: Merck seeks US authorization for COVID drug; EMA reviewing Regeneron, Roche COVID antibody

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck seeks first U.S. authorization for COVID-19 pill ( Reuters ) Roche says Alzheimer's therapy gets U.S. breakthrough designation ( Reuters ) U.S. CDC advisers to review Moderna, J&J COVID-19 booster shots this month ( Reuters ) Govt to control distribution of GSK/Vir COVID-19 antibody in U.S. – FDA ( Reuters ) Adamas, Flexion sell for $825M combined as de...