• Regulatory NewsRegulatory News

    FDA seeks comments on regulation of kratom, 6 other drugs

    Kratom, a popular but unregulated psychotropic herbal extract, is one of seven currently unscheduled psychotropic drugs that will be reviewed by the World Health Organization (WHO) under the provisions of the international psychotropic convention to which the US is a party.   WHO notified the US and other international parties to the 1971 convention that the seven new psychotropic drugs may be added to its list of scheduled drugs. By law, that notification triggers a r...
  • Regulatory NewsRegulatory News

    FDA declines to extend nitrosamine risk assessment deadline

    The US Food and Drug Administration (FDA) rejected pleas from the pharmaceutical industry to extend the deadline for conducting nitrosamine risk assessments to 1 September, standing firm on the 31 March deadline.   Industry representatives also told FDA to align its guidance with the International Council on Harmonization’s M7 guidance on impurity testing, saying  that divergent expectations have “created many challaneges for the pharmaceutical industry and increased ...
  • Regulatory NewsRegulatory News

    EMA adopts guideline on quality documentation for drug-device combination products

    The European Medicines Agency (EMA) has adopted a guideline on the quality information that manufacturers of combination products should submit in marketing authorization applications (MAA).   It also incorporates the recent revision of the EU’s Medical Devices Regulations (MDR) in requiring makers of these products to obtain the results of conformity testing of the device part from a notified body. The MDR regulation went into effect in May 2021. (RELATED: EMA Kicks...
  • ReconRecon

    Recon: Shape Therapeutics' $112M gene therapy play; Incyte's cancer drug flops at FDA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US At the FDA’s urging, Pfizer-BioNTech and Moderna are expanding their studies of children 5 to 11 ( NYT ) Bristol Myers withdraws Opdivo in liver cancer as fallout from FDA meeting continues ( Biopharma Dive ) Shelling out $5B+, PerkinElmer pays the big bucks for antibody and reagent player ( Endpoints ) House Democrats expand probe into political interference ...
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    House E&C leaders grill FDA on inspection backlog

    Leaders of the House Energy and Commerce committee on Thursday wrote to Janet Woodcock, the US Food and Drug Administration's (FDA) acting commissioner, requesting information about the agency's plans to address its inspection backlog driven by the lull in on-site inspections during the COVID-19 pandemic.   In March 2020, when the scope and seriousness of the pandemic became known, FDA halted all but mission-critical inspections, relying instead on alternative tools su...
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    FDA seeks new members for Patient Engagement Collaborative

    The US Food and Drug Administration is seeking eight new members for its Patient Engagement Collaborative (PEC), a group charged with gaining meaningful patient input into medical product development and regulatory decision making.   The 16-member panel includes patients, caregivers, and advocates who serve for 2 to 3 years. The panel is a joint effort between FDA and the Clinical Trials Transformation Initiative . Panel members are expected to participate in two to f...
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    Nouryant garners negative CHMP opinion for Parkinson's disease

    The human medicines committee of the European Medicines Agency (EMA) recommended two new medicines for approval during its July meeting; the committee also recommended four extensions of therapeutic indication and issued a negative opinion on one medicine.   Genzyme’s Nexviadyme (avalglucosidase alfa) was recommended by the Committee for Medicinal Products for Human Use (CHMP) to treat glycogen storage disease type II, also known as Pompe disease. Nexviadyme had receiv...
  • Feature ArticlesFeature Articles

    RWD, RWE, and improved patient outcomes: From FDA's Mini-Sentinel to real-world examples

    Uses of real-world data and evidence (RWD and RWE) have proliferated in recent years, driven by advances in data-gathering tools and methods and enhanced understanding of the value of such data and evidence. Under the 21st Century Cures Act of 2016, Congress codified RWD and RWE in the drug development and approval process. There are many opportunities for the use of RWD and RWE in the approval, labeling, clinical use, and marketing of medical products to enhance individu...
  • ReconRecon

    Recon: US buys 200M more doses of Pfizer vaccine; European Commission opens in-depth investigation into Illumina's bid to acquire Grail

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US United States buys 200 mln more doses of Pfizer/BioNTech COVID-19 vaccine ( Reuters ) CDC advisers hold off on Covid booster shot call ( Politico ) ( WSJ ) U.S. CDC advisers back J&J COVID-19 vaccine benefits amid neurological illness reports ( Reuters ) Facing Headwinds on New Alzheimer’s Drug, Biogen Launches Controversial Campaign ( KHN ) AstraZeneca's onc...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. Almost two dozen vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccine candidates that are still in development to address the lack of vaccines and access in many countries around the world; the second chart lists vaccines that are au...
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    EC announces €120 million in Horizon Europe funding

    The European Commission (EC) has pruned the list of COVID-19-related research projects it plans to fund, announcing Thursday a short list of 11 projects that will receive €120 million in total.   Funding for the projects will come from Horizon Europe, a research and innovation program that launched in 2021 and is planned to sunset by 2027. The program supports “urgent research” into COVID-19 with a focus on the emerging threats of variants of SARS-CoV-2, according to...
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    Woodcock: FDA needs expanded authority on device shortages

    The US Food and Drug Administration's (FDA) Acting Commissioner Janet Woodcock on Wednesday made a push for new funding to increase the resilience of the medical device supply chain and to expand the agency's authority to collect information about device shortages.   "The pandemic has exposed great weaknesses in the medical device supply chain and its dependence on foreign medical devices. To ensure the US is properly prepared now, and in the future, we must take actio...