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    UK Steps Back From ‘Leading Authority’ for Drugs in Brexit Transition

    The UK will not act as a “leading authority” for medicines during the one-year Brexit transition, although UK and EU negotiators are still trying to fine-tune what that means in practice, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in an updated guidance on Tuesday. The meaning of “leading authority” depends on interpreting Article 123 of the draft withdrawal agreement, which says : “During the transition period, the United Kingdom shall no...
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    Updated: Striking While the Iron is Hot: FDA Corrects New NDA, BLA Filings in Q1 of FY 2020

    As the US Food and Drug Administration (FDA) continues to approve more new drugs more quickly, the number of new application filings in the first quarter of FY 2020 (through 31 December 2019) seemed at first to have increased dramatically when compared to FY 2019 and 2018. FDA initially said this latest quarter saw 74 new drug application (NDA) filings and 32 biologics license application (BLA) filings, which compared with a total of only 26 BLA filings in all four quar...
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    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 17 February 2020 to include: Vifor Pharma said on 17 February that it p...
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    Modernizing ClinicalTrials.gov: NIH Seeks Feedback

    As part of a multi-year modernization initiative, the National Institutes of Health’s (NH) National Library of Medicine (NLM) is seeking comments from users and submitters to ClinicalTrials.gov on what can be done to improve the clinical research registry. The website is home to information on more than 300,000 clinical trials and since 2007, certain trials must be registered and information must be submitted to Clinicaltrials.gov. FDA in 2018 released draft guidance...
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    Rx-to-OTC Switches: FDA Signs Off on Three Drugs

    The US Food and Drug Administration (FDA) last Friday converted three prescription drugs to over-the-counter (OTC) drugs, increasing access to the medicines, including one for arthritis pain and two for redness of the eyes and itching due to allergies. The process of such prescription drug to OTC drug switches (known as Rx-to-OTC switches) is usually initiated by the manufacturer, FDA said. “For a drug to switch to nonprescription status, the data provided must demon...
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    Court Finds Sanofi Improperly Listed Insulin Device Patent in FDA’s Orange Book

    The US Court of Appeals for the First Circuit last week ruled that Sanofi improperly submitted a patent for its insulin device in the US Food and Drug Administration’s (FDA) Orange Book and could potentially be held liable for extending its monopoly. The case concerns Sanofi’s insulin glargine product Lantus, which first won FDA approval in 2000, and pulled in almost $8 billion in US sales in 2014. With its original application, Sanofi submitted a patent for listing ...
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    CBER Plots New Draft Guidance in 2020 on Genome Editing, CAR-T Therapies

    The FDA’s Center for Biologics Evaluation and Research (CBER) unveiled its 2020 guidance list on Friday, with new drafts coming on several increasingly crowded areas for drug development. Three new drafts this year will likely draw lots of comments from industry and other stakeholders. They deal with considerations for the development of Chimeric Antigen Receptor (CAR) T-cell therapies, considerations for the development of human gene therapies incorporating genome edit...
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    RWE: Cost and Time Savings Entice Sponsors as Pitfalls Linger

    The New England Journal of Medicine published an article earlier this week raising questions about the use of observational real world evidence (RWE), and how part of this drive toward using nonrandomized studies to assess the effects of treatments is due to the expensive and complex way that randomized clinical trials are being conducted. The timing of the article coincides with the US Food and Drug Administration (FDA) Commissioner Stephen Hahn recently pointing t...
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    CBER Raises Concerns With Cell Product Promoter RejuvaYou

    The US FDA’s Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research (CBER) earlier this week raised alarms with South Pasadena, CA-based RejuvaYou Medical Corporation, which claims to treat people with serious illnesses with umbilical cord blood and other cellular products. RejuvaYou markets the products to treat various diseases or conditions, including some that are serious or life-threatening, FDA’s untitled letter notes, and t...
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    Ireland’s NSAI Designated as 11th Notified Body Under MDR

    The National Standards Authority of Ireland (NSAI) was added to the European Commission’s NANDO database as the 11th notified body and first from Ireland to be designated under the EU’s Medical Devices Regulation (MDR), which takes effect on 26 May. The designation for the Dublin-based authority is for active implantable devices, active non-implantable devices, non-active implants and long term surgically invasive devices and non-active non-implantable devices, among ot...
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    Internal FDA Emails Reveal How Price, Sanders’s Pressure Played a Role in Competitor’s Approval, Catalyst Claims

    A series of partially redacted internal emails from the US Food and Drug Administration (FDA), released as part of a lawsuit related to competing treatments for the rare disorder Lambert-Eaton Myasthenic Syndrome (LEMS), attempt to show how price and Sen. Bernie Sanders’s (D-VT) pressure played a role in FDA’s approval of a competitor. The case concerns Catalyst Pharmaceuticals, which sued FDA last June in the US District Court for the Southern District of Florida bec...
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    FTC Sues Two Supplement Companies to Stop Unverified Marketing Claims

    The Federal Trade Commission (FTC) said this week that it has sued two companies that made unsubstantiated claims while marketing their products containing the active ingredient cyplexinol. One of the companies, Excellent Marketing Results, Inc. (EMR) and its president, agreed to settle with the FTC and will be prohibited from making health-related product claims unless they are supported by scientific evidence. The proposed order imposes a $3.6 million judgment against...