• Regulatory NewsRegulatory News

    Regulatory science pilot floated in BsUFA III negotiations

    In the latest rounds of negotiations for the reauthorization of the Biosimilar User Fee Act (BsUFA III), industry and the US Food and Drug Administration (FDA) fine-tuned labeling and supplements language, sought to find new ways for developers to receive targeted feedback, and set the scope for future guidance documents.   In a series of three May 2021 meetings, the BsUFA III negotiation steering committee convened to work on these topics, and to hammer out an agreeme...
  • Feature ArticlesFeature Articles

    Best practices and education for probiotics amid regulatory uncertainty

    Nearly 3 years have passed since the US Food and Drug Administration (FDA) issued its draft guidance for industry on the labeling of probiotic quantity. During that time, consumer interest in probiotics has increased, product innovation has expanded, and the body of scientific research has grown – all with no final guidance or updates from the agency. With the growth of this category and continued regulatory uncertainty, responsible industry has stepped up with best practi...
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    FDA launches global Generic Drug Cluster

    In a new effort to boost alignment of scientific and regulatory approaches to generic drug development among global regulators, the US Food and Drug Administration is standing up a Generic Drug Cluster.   Described as “the first forum established for the world’s leading regulatory agencies to address generic drug development globally,” the new cluster, wrote FDA, is meant to help harmonize approaches global regulators take to generic drug development through a variety ...
  • ReconRecon

    Recon: Novavax COVID-19 vax 90%-plus effective; GSK pays big for Iteos' TIGIT-targeted immunotherapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novavax Offers U.S. a Fourth Strong Covid-19 Vaccine ( NYT ) ( NPR ) ( Reuters ) Another Sad Coronavirus Pandemic Milestone Is Approaching ( NPR ) U.S. Not On Pace To Meet Biden's Vaccination Goal ( NPR ) Eight states see rise in new COVID-19 infections ( The Hill ) U.S. has administered over 309 million doses of Covid-19 vaccines, CDC says ( CNBC ) How did ...
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    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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    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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    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...