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    FDA adcomm unanimous on J&J boosters for all

    The vaccines advisory committee of the US Food and Drug Administration (FDA) voted unanimously Friday to recommend a full-strength booster dose of the COVID-19 vaccine made by Janssen, the vaccines arm of Johnson & Johnson, for all recipients of the single-dose primary vaccination.   The Vaccines and Related Biologic Products advisory committee (VRBPAC) recommended that FDA issue an emergency use authorization (EUA) for a booster to be given at least 2 months after the...
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    Unanimous thumbs up from FDA committee for Moderna booster

    An advisory committee to the US Food and Drug Administration (FDA) voted unanimously to recommend a half-strength booster dose of the mRNA COVID-19 developed by Moderna and the National Institutes of Health for those 65 years and older, and for certain younger populations at high risk of severe COVID-19.   Moderna has requested an emergency use authorization (EUA) for the 50 mcg booster dose for individuals who have already completed the two-dose series of the Moderna ...
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    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...
  • 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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    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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    EMA readies CTIS go-live plan

    A new electronic information system for clinical trial reporting in the EU is one step closer to launch with the European Medicines Agency’s (EMA’s) Thursday publication of a go-live planning document.   The 12-page document covers key steps remaining before the launch of the Clinical Trial Information System (CTIS), planned for 31 January 2022, and follows an April 2021 audit by EMA’s management board that confirmed that CTIS is “fully functional and meets the agreed ...
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    FDA recognizes Memorial Sloan Kettering tumor variant database

    The first somatic human variant database has been recognized by the US Food and Drug Administration for inclusion in its Public Human Genetic Variant Database listing. The move opens the door for developers of tumor profiling tests to use the database to support clinical validity claims in regulatory submissions.   A portion of Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OnkoKB) received the recognition under FDA’s database recognition program. ...
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    New guide to clinical trial lay summaries available for EU sponsors

    The European Commission (EC) has laid out recommendations on best practices for preparation, translation and dissemination of lay summaries of clinical trial information, intended both for trial participants and the general public, in a newly published document.   The EC’s Clinical Trials Expert Group (CTEG) adopted the guidelines in July 2021; the 85-page document walks users through the lay summary (LS) process from the planning and scoping stage, through the develop...
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    For gene therapies, FDA drafts trial guidance, finalizes "sameness" for orphan exclusivity

      A new draft guidance from the US Food and Drug Administration (FDA) gives cell and gene therapy developers a detailed framework for the conduct of umbrella trials, offering the potential for enhanced speed and efficiency in early-stage clinical trials.   In the umbrella trials envisioned under the draft guidance, two or more versions of a cellular or gene therapy product would be studied for one specific disease using just one trial design, shared infrastructure, a...
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    Drugs for non-TB pulmonary disease see new FDA guidance

    A new draft guidance from the US Food and Drug Administration (FDA) lays out considerations for sponsors who are developing drugs to treat certain lung infections caused by a mycobacterium related to the organism that causes tuberculosis.   The draft, posted to the FDA website on Tuesday, guides developers of drugs to treat nontuberculous mycobacterial pulmonary disease caused by Mycobacterium avium complex (MAC). It follows an April 2019 public workshop held by FD...
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    FDA OKs new pathology AI software, launches AI-enabled device database

    The US Food and Drug Administration (FDA) has authorized software designed to help pathologists detect prostate cancer in digitally scanned slides from prostate biopsies. Separately, the agency announced Wednesday that it has made available a list of devices that use artificial intelligence and machine learning.   The newly authorized software, called Paige Prostate, is the first artificial intelligence (AI) tool okayed by FDA for in vitro diagnostic use for prostate...