• Regulatory NewsRegulatory News

    FDA clarifies potential actions when onsite inspections are infeasible

    The US Food and Drug Administration (FDA) on 17 May revised its question-and-answer guidance on inspections during the COVID-19 pandemic to clarify the regulatory actions it plans to take when it cannot conduct an onsite inspection of a facility.   FDA announced that while the pandemic continues to restrict onsite inspections, the agency “intends to continue using alternative tools to evaluate facilities.” FDA continues to conduct onsite inspections for those products ...
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    FDA: Flexibility okay for gaps in gene therapy trials

    The US Food and Drug Administration (FDA) is not amenable to changing study endpoints or sample sizes for gene therapy clinical trials but is encouraging sponsors to fill in gaps in data collection with telemedicine and remote visits.   Wilson Bryan, director of the FDA’s Office of Tissues and Advanced Therapies (OTAT) in FDA’s Center for Biologics Evaluation and Research, told a 12 May meeting of the American Society of Gene and Cell Therapy that the pandemic is promp...
  • ReconRecon

    Recon: FDA rebukes CytoDyn over COVID drug claims; BMS to pay up to $1.4B for Agenus cancer drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA issues major rebuke to CytoDyn over claims on Covid-19 drug ( STAT ) ( Endpoints ) ( FDA ) Biden Pledges to Export Millions of FDA-Authorized Vaccines ( Bloomberg ) ( Reuters ) ( Politico ) Bristol to pay up to $1.38B to develop, sell Agenus's cancer therapy ( Reuters ) ( Endpoints ) ( Press ) Roche COVID test receives U.S. greenlight for asymptomatic peop...
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    Asia-Pacific Roundup: Vietnam seeks mRNA tech transfer for local COVID vaccine production

    The Vietnamese health ministry has met with the World Health Organization (WHO) to discuss the transfer of the technology needed to manufacture mRNA vaccines in the country.   Vietnam received a shipment of 811,200 doses of the COVID-19 vaccine developed by AstraZeneca and the University of Oxford via the COVAX Facility at the start of last month. Around 900,000 people have now received a vaccine, but the supply of doses remains a constraint on the pace of the rollou...
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    Drug labeling authority, UDI program reviewed by Harvard-based researchers

    Two papers in JAMA Internal Medicine highlighted separate, but important issues concerning the US Food and Drug Administration’s authority to modify package inserts and the effect of a recently shuttered agency initiative.   In a Viewpoint, Bishal Gyawali, MD, PhD, and colleagues at the Program on Regulation, Therapeutics and Law (PORTAL) research group at Harvard Medical School and Brigham & Women’s Hospital suggested improving FDA’s authority to modify drug package...
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    FDA issues new COVID-19 master protocol guidance

    A new guidance from the US Food and Drug Administration (FDA) addresses how master protocols can be used in developing drugs to treat or prevent COVID-19.   “To meet the urgent demand for effective therapies, FDA has worked with clinical trial experts to rapidly advance best practices in the design and execution of clinical trials,” said acting FDA Commissioner Janet Woodcock in announcing the new guidance. “Master protocols that are well designed and executed can acce...
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    MDCG prods COVID diagnostic makers to assess variants

    The European Commission’s Medical Device Coordination Group (MDCG) sent a notice to in vitro diagnostic (IVD) makers and their authorized representatives reminding them of their obligation to assess the impact of COVID-19 variants on the performance of their tests.   “The notice underlines the manufacturers’ responsibilities to continually assess the impact of newly identified genetic variants of SARS-CoV-2 on the capability of those IVDs to meet their performance, r...
  • Recon: Sanofi, GKS report positive interim results for COVID shot; Regeneron resumes lymphoma trials after hold lifted

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Covid-19 Drugmakers Take On Your Favorite TV Shows to Tackle Vaccine Hesitancy ( WSJ ) Trump tax law cut what US drugmakers owed. Now they fear an increase. ( BioPharmaDive ) Regeneron resumes enrollment in lymphoma drug trials ( Reuters ) Incyte's vitiligo treatment meets main goal in late-stage trial ( Reuters ) US Supreme Court denies Sandoz petition to...
  • Feature ArticlesFeature Articles

    EU IVDR countdown: Opportunities await, but concerns linger over notified bodies

    It is essential for manufacturers of in vitro diagnostics (IVDs) to understand the full scope of changes under the May 2022 In Vitro Diagnostic Regulation (IVDR) to ensure compliance with the new regulations and seamless placement and maintenance of safe, effective products on the EU market and streamline access to the larger global market. One note of caution, however, is that EU-certified IVDR notified bodies (NBs) are overwhelmed with product review applications and tim...
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    Euro Convergence: Academic clinics should establish risk management programs for ATMP development

    Academic centers should establish risk management programs to successfully commercialize cell and gene therapy products and to be a viable partner with contract research organizations (CROs) and manufacturers in developing these therapies.   So asserted Lutz Uharek, a professor of internal medicine and founder and CEO of Xencura, at RAPS Euro Convergence 2021 on 12 May in discussing some of the challenges and opportunities for academic centers in developing cell and ge...
  • OSE's annual report details Sentinel efforts during COVID pandemic

    The US Food and Drug Organization’s (FDA’s) Office of Surveillance and Epidemiology issued its first-ever annual report summing up the office’s work.   The scope of the office’s charge meant that during the pandemic, staff effort was largely directed toward addressing the global public health emergency of the COVID-19 pandemic, noted Gerald Dal Pan, director of FDA’s Office of Surveillance and Epidemiology (OSE).   However, OSE also continued its efforts in other a...
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    FDA cautions cell phones, smart watches may trigger magnet mode in implanted devices

    High field strength magnets in some consumer electronic devices may trigger “magnet mode” in certain implanted medical devices such as pacemakers and cardiac defibrillators, the US Food and Drug Administration said on Thursday.   Many implanted electronic medical devices feature a magnet mode to allow the safe operation of the device during medical procedures such as an MRI scan. While in magnet mode normal device operations are suspended and the mode is typically enga...