• RoundupsRoundups

    Asia Regulatory Roundup: India Commits to Phased Overhaul of Medical Device Regulations

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Commits to Phased Overhaul of Medical Device Regulations   The Indian government has set out the timeline for moving to a new regulatory system for medical devices. Officials intend to institute a law that will increase oversight of all medical devices on 1 April but will defer enforcing the new requirements for upward of 18 months.   Last year, the Indian ...
  • Regulatory NewsRegulatory News

    FDA Touts Generic Drug Research in 2019

    The US Food and Drug Administration (FDA) on Tuesday released a report detailing the scientific research carried out and funded by the agency in FY2019 to support the development of generic drugs under the Generic Drug User Fee Amendments (GDUFA II).   The 83-page report provides an overview of the research activities related to 13 research areas that fit within the four scientific priorities FDA set for FY2019, which include: complex active ingredients, formulatio...
  • Regulatory NewsRegulatory News

    ICH E9(R1) and S5(R3) to Take Effect in EU by End of July

    More than two years after opening public consultations on the guidelines, the European Medicines Agency (EMA) on Tuesday adopted two International Council for Harmonisation (ICH) guidelines, the ICH E9(R1) addendum on estimands and sensitivity analysis in clinical trials and ICH S5(R3) on reproductive toxicology, with both guidelines set to take effect on 30 July 2020.   EMA’s move to adopt the guidelines comes after ICH adopted the E9(R1) addendum at its November meet...
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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...
  • Regulatory NewsRegulatory News

    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...
  • Feature ArticlesFeature Articles

    Demonstrating Regulatory Value

    This article discusses the critical role of regulatory and highlights the value regulatory professionals bring to an organization in terms of their contribution to cost savings and eventual product earnings.   Introduction   In the current economic environment, biopharmaceutical sponsors are being asked to achieve more with less resources. The critical role of regulatory needs to be highlighted in terms of their contribution to cost savings and eventual product ear...
  • ReconRecon

    Recon: Sanofi/BARDA Team Up on Coronavirus Vaccine; NHS Starts Luxturna Gene Therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sanofi announces it will work with HHS to develop coronavirus vaccine ( STAT ) ( Reuters ) ( Press ) The top 100 biopharma venture investors at the megabillions deal table ( Endpoints ) ‘Pharma doesn’t like fish oil’: Wall Street funds sold Amarin after big win with heart drug ( STAT ) FDA goes on high alert as coronavirus raises threat to drug manufacturing a...
  • Regulatory NewsRegulatory News

    Coronavirus Prompts IMDRF to Cancel 3 Meetings

    In consideration of the ongoing coronavirus (COVID-19) outbreak, the International Medical Device Regulators Forum (IMDRF) has cancelled three upcoming meetings in Singapore.   The three meetings were to be held from 16-19 March and include the IMDRF-DITTA Joint Workshop on Cybersecurity, IMDRF Stakeholder Forum and the IMDRF Management Committee Meeting.   According to the latest World Health Organization (WHO) situation report , there are now more than 71,000 co...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • ReconRecon

    Recon: BMS Reports Long Term Results for Opdivo in Kidney Cancer; Cancer Drug Shortages Hit Mexico’s Public Health System

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US DOJ’s Generic Drug Criminal Probe Snares Ex-Sandoz Exec ( Law360 -$) ( DoJ ) BMS unveils long-term results for Opdivo in kidney cancer ( PMLive ) ( Press ) ( Press ) N-of-1 drugs push biopharma frontiers ( Nature ) A city in Georgia is the latest to sue Mallinckrodt over its pricey Acthar Gel medicine ( STAT ) Solving the mystery of Vifor’s new voucher ( Vant...