• TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. Almost two dozen vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccine candidates that are still in development to address the lack of vaccines and access in many countries around the world; the second chart lists vaccines that are au...
  • Regulatory NewsRegulatory News

    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...
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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...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    More than a year into the pandemic, only a handful of repurposed therapeutics have been approved to treat COVID-19: dexamethasone in the UK and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the US, UK and Japan.   Regulators around the world have allowed a handful of treatments to be used on an emergency-use basis including Eli Lilly and Company’s monoclonal antibodies bamlanivimab with etesevimab; Regeneron’s casirivimab and imdevim...
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    FDA proposes to refuse Intarcia’s exenatide combo product NDA —again

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has told Intarcia Therapeutics it is proposing to refuse a new drug application for their type 2 diabetes drug-device combination product ITCA 650.   In a notice posted in the Federal Register , the agency said Intarcia can request a hearing from FDA on the proposal, but if the hearing is waived or it is determined the reason for the hearing isn’t sufficient, FDA will move forwa...
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    CBO: Proposed Medicare pricing plan could curb drug development

    A new drug development model released by the Congressional Budget Office (CBO) estimates a Medicare drug pricing bill like the one proposed by Democrats in the US House of Representatives could result in between 21 and 59 fewer drugs brought to market over the next three decades.   The Elijah E. Cummings Lower Drug Costs Now Act ( H.R. 3 ), introduced in the 116th Congress during the 2019-2020 legislative session, would require the Secretary of Health and Human Servi...
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    FDA updates safety communication for robotically assisted surgical devices used in mastectomy

    The safety and effectiveness of robotically assisted surgical devices has yet to be established in the prevention and treatment of breast cancer, according to an updated safety communication released by the US Food and Drug Administration (FDA).   The agency reiterated that use of these devices has been cleared for procedures such as hysterectomy, prostatectomy, and colectomy based on data from 30-day patient follow-up. However, robotically assisted surgical (RAS) devi...
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    FDA approves Comirnaty as first COVID vaccine

    The US Food and Drug Administration (FDA) has approved Pfizer and BioNTech’s mRNA COVID-19 vaccine, Comirnaty, for people 16 years or older.   The announcement represents not just the first approved COVID-19 vaccine in the US, but also the first-ever approval for an mRNA therapy.   “This is a pivotal moment for our country in the fight against the pandemic,” FDA Acting Commissioner Janet Woodcock, MD, said during a media briefing on the vaccine’s approval. “While t...
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    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...
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    FDA reaffirms that CBD products can’t be marketed as dietary supplements

    The US Food and Drug Administration (FDA) has objected to New Dietary Ingredient (NDI) notifications submitted by two developers of full-spectrum hemp extract products, telling the companies an earlier decision by the agency to consider cannabidiol (CBD) as a drug means it won’t consider their applications to sell the products as dietary supplements.   Writing to Irwin Naturals, FDA said the company’s product, NDI 1199, contains CBD, which is an active ingredient in Ep...
  • Regulatory NewsRegulatory News

    After court defeat, FDA shifts to regulating some drugs as devices

    The US Food and Drug Administration (FDA) is informing stakeholders and the public that it will soon begin implementing a court decision that may require the agency to transition some products approved as drugs to be regulated as devices.   In April, FDA lost a court battle ( Genus Med. Techs., LLC v. FDA , 2021 U.S. App. Lexis 10928) in the US Court of Appeals for the District of Columbia Circuit when it argued it had the ability as a regulatory authority to classify ...
  • Regulatory NewsRegulatory News

    FTC to focus enforcement action on illegal repair restrictions

    In a unanimous vote, the Federal Trade Commission (FTC) has decided to focus law enforcement efforts on repair restrictions that impede or prevent consumers and businesses from repairing products they own.   “While unlawful repair restrictions have generally not been an enforcement priority for the Commission for a number of years, the Commission has determined that it will devote more enforcement resources to combat these practices,” FTC said in a new policy statemen...