• Regulatory NewsRegulatory News

    FDA panel split on approach to COVID-19 vaccines for younger children

    Members of the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) disagreed as to whether the agency should grant emergency use authorizations (EUAs) for COVID-19 vaccines for children at a 10 June meeting.   Some said that EUAs were necessary to get the pediatric population vaccinated quickly to achieve herd immunity as the country emerges from the pandemic and that these vaccines should be available soon as th...
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    Warning letter: FDA blasts Innova for falsifying data, GMP violations

    Editor's note: This article has been updated to include a statement from Innova. The US Food and Drug Administration issued a warning letter on 10 June to Innova Medical Group for distributing unauthorized SARS-CoV-2 rapid antigen tests and "false or misleading" information in the tests’ labeling.   The warning letter comes after FDA inspected two of the firm’s facilities in Pasadena and Brea, CA over the course of several weeks in March and April.   FDA also ...
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    FDA to study disclosure information for accelerated approval products in oncology

    The Office of Prescription Drug Promotion (OPDP) at the US Food and Drug Administration (FDA) wants to know how to better present disclosure information about products with accelerated approval to patients with cancer and their caregivers.   In two studies recently announced in the Federal Register , OPDP is seeking to confirm prior research on how patients interpret disclosure information for a product approved under FDA’s accelerated approval pathway on a direct-to-...
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    Recon: FDA asked J&J to discard 60M vaccine doses made at Emergent plant; EMA adds rare blood condition as side effect of AZ shot

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA tells J&J that 60M doses made at Emergent plant cannot be used ( NYTimes ) ( Reuters ) ( Politico ) J&J vaccine doses to be released, but many will be tossed ( AP ) ( Axios ) ( FDA ) FDA faces mounting criticism over Alzheimer’s drug approval ( Reuters ) Eli Lilly memo says firm did not make false statements to FDA ( Reuters ) Controversial drug approval ...
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    Recon: FDA extends shelf life of J&J vaccine; Ocugen to seek BLA for its COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to donate 500 million Pfizer doses to poor nations ( Reuters ) ( Politico ) US is in discussions with Moderna on buying Covid vaccine doses for other nations ( CNBC ) Moderna files for US authorization to use its COVID-19 vaccine in teens ( Reuters ) ( NYTimes ) FDA extends shelf life of Johnson & Johnson COVID-19 vaccine ( Reuters ) Ocugen to file for ful...
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    FDA releases draft guidance on assessment of PROs for cancer trials

    The US Food and Drug Administration (FDA) has released a draft guidance that recommends how sponsors can collect “meaningful” patient-reported outcome (PRO) measurements to assess results from cancer clinical trials.   The draft guidance focuses on a set of “core” PRO measures that can be used to gather data on patients’ symptoms, symptomatic adverse events and physical function and is specific to registration trials for anti-cancer treatments intended to demonstrate...
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    Recon: US signs for $1.7M courses of Merck’s experimental COVID drug; FDA approves Vertex CF drug for 6-11 year olds

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden says he will be announcing a vaccine plan for the world ( Reuters ) White House urges states to seek longer shelf life for J&J shots as millions near expiration ( Reuters ) ( KHN ) ( Politico ) US signs $1.2 bln deal for 1.7 mln courses of Merck's experimental COVID-19 drug ( Reuters ) ( HHS ) Vertex cystic fibrosis treatment gets U.S. approval for use i...
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    FDA disappointed with slow uptake of approvals for stem cell therapies

    At a recent meeting, a US Food and Drug Administration official said the agency is “concerned” about the slow uptake from companies seeking regulatory approval to market and distribute stem cell therapies and is therefore stepping up their enforcement efforts against companies making unapproved therapies.   Wilson Bryan, director of FDA’s Office of Tissues and Advanced Therapies (OTAT) in FDA’s Center for Biologics Evaluation and Research, told attendees of an 8 June m...
  • RoundupsRoundups

    FDA Approvals Roundup: Aduhelm, Brexafemme, Tembexa

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Aduhelm okayed for slowing Alzheimer’s by targeting disease-driving process Biogen’s Aduhelm (aducanumab) has received accelerated approval for treating patients with Alzheimer’s disease, making it the first new treatment for the disease since 2003.   The human monoclonal antibody is also a first-of-its kind therapy for the disease in that...
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    Friends of Cancer Research project tracks early cancer therapy response

    The Friends of Cancer Research (FCR) has launched the next stage of a project that studies whether circulating tumor DNA changes can be used to track early response to cancer therapies.   The launch of Step 2 of the Circulating Tumor DNA for Monitoring Treatment Response (ctMoniTR) Project will involve data collection from over 3,000 cancer patients participating in more than 25 studies, said FCR in announcing the launch. Sixteen additional cancer treatments involving ...
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    Biden administration outlines plan to address US supply chain vulnerabilities

    The United States is taking steps to address vulnerabilities in US supply chains, according to a new report published by the White House.   These steps include improving domestic manufacturing of critical medicines and active pharmaceutical ingredients, increasing investments in sustainable domestic supply chains, and better monitoring of supply chain disruptions, the Biden administration said.   On Monday, the Biden administration released a report of findings f...
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    FDA’s FY22 budget priorities: boost inspections, surveillance; avert device shortages

    The US Food and Drug Administration’s FY 2022 budget request to Congress indicates the agency’s wishes to catch up on the backlog of inspections that have been delayed due to COVID-19, improve its drug surveillance efforts to detect possible shortages, and avert shortages for such medical devices as personal protective equipment (PPE).   Many of these requests have been driven by the need to combat device and drug shortages wrought by the pandemic.   The request al...