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    Pharmacogenetics: FDA Releases Table of Gene-Drug Interactions

    The US Food and Drug Administration (FDA) on Thursday published a table identifying more than 50 gene-drug interactions that the agency says are supported by scientific evidence and announced it is considering new approaches to evaluating pharmacogenetic associations.   “Consistent with our mission to protect and promote public health, we believe it is important to take steps now to help ensure that claims being made for pharmacogenetic tests offered today are grounded...
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    FDA Finalizes ‘Biological Product’ Definition Ahead of BPCIA Transition

    A month before the long-anticipated transition of applications for certain biological products, including insulin and human growth hormone, to be deemed to be licensed as biologics, the US Food and Drug Administration (FDA) on Thursday issued a final rule amending its definition of “biological product.”   The final rule is one of the last steps in the decade-long transition set in motion by the Biologics Price Competition and Innovation Act of 2009 (BPCIA) to deem ap...
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    Recon: GSK, Immatics Partner on Immunotherapies; Teva’s Austedo Fails in Two Tourette’s Studies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA deems Abbott Vascular, ResMed, Teleflex recalls high risk ( MedtechDive ) Fisher Wallace files citizen petition over FDA’s class III designation for CES ( BioWorld ) AI discovers antibiotics to treat drug-resistant diseases ( Financial Times ) ( STAT ) Lawmakers to Trump: Don’t give ‘monopolies’ to companies that develop coronavirus treatments with taxpaye...
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    Health Canada Begins Implementing eCTD for Clinical Trial Applications

    Following a successful pilot that wrapped up in August, Health Canada says it will immediately begin accepting certain clinical trial submissions in electronic common technical document (eCTD) format.   In recent years, Health Canada has moved to increasingly accept or require eCTD format for various submissions, including new drug submissions (NDS), abbreviated new drug submissions (ANDS) and drug master files (DMFs).   Specifically, Health Canada says it will all...
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    FDA Consolidates Nonclinical Immunotoxicity Evaluation Guidance

    The US Food and Drug Administration (FDA) on Wednesday issued a new draft guidance consolidating its recommendations on nonclinical safety evaluations for immunotoxicity and withdrew an earlier 2002 guidance on the topic.   FDA says the guidance addresses issues related to evaluating immunotoxicity including immune suppression, modulation and stimulation and provides recommendations for carcinogenicity assessments, dermal sensitization, adjuvanted vaccine development a...
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    Recon: Roche Nabs Priority Review for Tecentriq in NSCLC; FDA Rejects 6-Week Dosing Schedule for Keytruda

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump's next health care move: Giving Silicon Valley your medical data ( Politico ) How the Drug Lobby Lost Its Mojo in Washington ( WSJ ) FDA sets June decision date for Tecentriq monotherapy in NSCLC ( PMLive ) ( Press ) FDA rejects Merck’s applications for 6-week Keytruda dosing schedule ( Reuters ) ( Press ) BMS’ Opdivo combo misses the mark in pancreatic...
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    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...
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    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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    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...
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    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...
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    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...
  • 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...