• 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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    FDA releases draft guidance on assessment of PROs for cancer trials

    The US Food and Drug Administration (FDA) has released a draft guidance that recommends how sponsors can collect “meaningful” patient-reported outcome (PRO) measurements to assess results from cancer clinical trials.   The draft guidance focuses on a set of “core” PRO measures that can be used to gather data on patients’ symptoms, symptomatic adverse events and physical function and is specific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...
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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...
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    Smallpox antiviral approved under FDA’s Animal Rule

    Though the World Health Organization declared smallpox eradicated in 1980, FDA has approved Tembexa (Chimerix,brincidofovir) as a treatment for the contagious, deadly disease caused by the variola virus.   The 4 June announcement of Tembexa’s approval noted that smallpox drug development is “an important component of the US medical countermeasures response,” since the federal government has significant concerns about the virus’ potential use as a bioweapon. Tembexa was...
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    FDA approves aducanumab for use in Alzheimer’s disease

    The U.S. Food and Drug Administration (FDA) on Monday announced the approval of Biogen’s human monoclonal antibody Aduhelm (aducanumab) for use in patients with Alzheimer’s disease under the agency’s accelerated approval pathway.   FDA’s approval of aducanumab is based on results from two Phase 3 clinical trials of patients with early Alzheimer’s disease (AD), EMERGE and ENGAGE . Both trials were stopped in March 2019 due to apparent futility by a data safety monito...
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    FDA details plans for DSCSA implementation in four guidances

    The US Food and Drug Administration (FDA) on 3 June released four guidances on its plans for implementing the Drug Supply Chain Security Act (DSCSA), setting the agency’s expectations for how pharmaceutical manufacturers should comply with new product tracing requirements.   They address situations that can increase the risk of suspect products entering the supply chain, expectations for product identifiers, interoperable electronic tracing of products and definition...