• Regulatory NewsRegulatory News

    HHS, FDA dispute spills out onto Twitter

    In the final months and weeks of the Trump administration, the Department of Health and Human Services (HHS) has advanced several policies to consolidate its authority over the US Food and Drug Administration’s (FDA). Today, with just one day left in the Trump administration, the latest dispute between HHS and its subagency spilled into the public. Following media reports last week that FDA Commissioner Stephen Hahn refused to sign a memorandum of understanding (Mo...
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    CBER lays out volume-staff mismatch in PDUFA VII meetings

    During an 11 December public stakeholder meeting, FDA met with representatives of patient and consumer advocacy groups as the Prescription Drug User Fee Act (PDUFA) VII reauthorization process continues.   The meeting, held virtually, began with a review of the cell and gene therapy review programs overseen by FDA’s Center for Biologics Evaluation and Research (CBER). Wilson Bryan, MD, of CBER’s Office of Tissues and Advanced Therapies (OTAT), told attendees at the vir...
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    Asia-Pacific Roundup: TGA moves to strike redundant, resource intensive processes

    Australia’s Therapeutic Goods Administration (TGA) has outlined plans to eliminate certain redundant, resource intensive processes to lessen the burdens on its teams and the companies it regulates. The proposal centers on information uploaded to a Proprietary Ingredients Table that stores information about mixes of excipients and actives.   Today, TGA asks ingredient suppliers to add information to the table by completing a form covering the constituent ingredients of ...
  • ReconRecon

    Recon: Independent review critical of delayed pandemic response; US Supreme Court rejects Merck hep C patent appeal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Small biotech launches human trials of a potential ‘backstop’ for Covid-19 vaccines ( STAT ) Will the FTC get tougher on pharma business practices under the Biden administration? ( STAT ) Supreme Court rebuffs Merck appeal in hepatitis C patent fight with Gilead ( Reuters ) ( Law360 ) Mylan loses bid to dismiss EpiPen antitrust claims ( Reuters ) How Operatio...
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    FDA explains convalescent plasma donor eligibility for COVID vaccine recipients

    The US Food and Drug Administration (FDA) last week revised its guidance on COVID-19 convalescent plasma to clarify when COVID-19 vaccine recipients can qualify as donors for plasma collected under the agency’s emergency use authorization (EUA) for convalescent plasma.   (RELATED: Lawmakers, experts raise questions after convalescent plasma EUA , Regulatory Focus 25 August 2020; COVID convalescent plasma guidance gets EUA updates , Regulatory Focus 3 Septembe...
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    FDA allows modifications to coagulation monitoring systems for COVID-19

    The US Food and Drug Administration (FDA) is allowing manufacturers to modify coagulation systems for measuring whole blood viscoelastic properties to allow for greater use in hospitals for the supportive management of patients with COVID-19.   The enforcement policy , which was issued in January 2021, is temporary and will remain in effort only for the duration of the COVID-19 public health emergency.   “As hypercoagulability has been observed in patients with CO...
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    Perspective: Drug price transparency in the Biden era

    The Trump administration’s efforts to increase drug price transparency are likely to survive the transition to the Biden administration, according to a perspective piece published 13 January in the New England Journal of Medicine . Included in the Transparency in Coverage final rule, issued in late October 2020, the drug price transparency provisions aim to require that health insurers publish list prices and historical net prices for prescription drugs. The inform...
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    FDA’s AI/ML action plan includes ‘tailored’ regulatory framework for SaMD

    The US Food and Drug Administration has released a five-part action plan for its oversight of artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) based on feedback from developers and manufacturers on an April 2019 discussion paper.   Top of the action-plan list is the agency’s intention to develop a “tailored” regulatory framework for the medical software by issuing draft guidance on the Predetermined Change Control Plan outl...
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    Recon: FDA approves Daiichi’s Enhertu for certain gastric adenocarcinomas; Norway says advice on Pfizer vaccine unchanged

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AstraZeneca, Daiichi's breast cancer drug gets broader US approval ( Reuters ) ( FDA ) Biden will keep Dr. Francis Collins as National Institutes of Health director: statement ( Reuters ) Biden warns of challenges ahead as he rolls out new vaccine plan ( Politico ) Biden Administration Will Rename 'Operation Warp Speed,' Citing Trump 'Failures’ ( NPR ) ( Polit...
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    Cyberattack: EMA says leaked documents ‘manipulated’

    Documents related to COVID-19 vaccines that were unlawfully accessed in a cyberattack against the European Medicines Agency (EMA) and subsequently leaked online were intentionally manipulated, the agency said on Friday.   EMA first disclosed the hack in December and said at the time it had launched a full investigation in cooperation with law enforcement and other authorities. Since then, vaccine frontrunners Pfizer and BioNTech and Moderna have released statements ack...
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    FDA issues guidance on resuming or initiating BE studies amid pandemic

    New guidance from the US Food and Drug Administration (FDA) issued on Friday provides recommendations for resuming or initiating bioequivalence (BE) studies for generic drugs during the COVID-19 pandemic.   The guidance, aimed at ensuring participant and study staff safety, calls on generic drug developers to carefully consider protocols for resuming or initiating BE studies and to take steps to ensure the scientific validity of data generated from studies impacted by ...
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    PREPP initiative: FDA’s COVID-19 response and the path forward

    The US Food and Drug Administration (FDA) has adapted in its response to the COVID-19 pandemic, from increasing transparency of its risk-benefit analyses for emergency use authorizations (EUAs) to providing guidance on vaccine development, according to a summary report of the agency’s COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative.   The report catalogues the agency’s work during the pandemic, noting that it has published and revised more than 65...