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    CDRH official offers advice for smoother Q-submission meetings

    A policy analyst with the US Food and Drug Administration (FDA) walked through mechanisms the medical device industry can use to request pre-submission meetings, as well as best practices for ensuring smooth reviews.   Susannah Gilbert, Q-submission program lead with the division of regulatory programs at FDA’s Center for Devices and Radiological Health (CDRH), gave the updates at a 21 July webinar sponsored by the FDA’s Small Business Regulatory Education for Industry...
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    CBER targets four stem cell firms with untitled letters

    The US Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA’s CBER) recently issued untitled letters to four companies for marketing unapproved stem cell products, indicating that despite the end of an enforcement grace period, companies are still resisting the agency’s efforts to get these products approved.   Effective June 1, companies are required to file biologics license applications for stem cell therapies that claim to treat a diseas...
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    Global regulators promote platform trials to assess new COVID vaccines

    Regulators from the United Kingdom and Japan are promoting the use of platform trials to evaluate second-generation COVID-19 vaccines as the pool of unvaccinated patients for testing new vaccines grows increasingly smaller. They also proposed the creation of a working group to build consensus on the design of master protocols, particularly in the context of health emergencies.   These pronouncements emerged from a 24 June virtual workshop on aligning approaches for dev...
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    Industry consortium releases blueprint for DSCSA tracking systems

    An industry consortium has recently released the first chapter of a blueprint to help guide the pharmaceutical industry in setting up electronic systems to track their products through the supply chain.   The PDG Blueprint was released by the Partnership for DSCSA Governance (PDG), a consortium of more than 60 pharmaceutical supply chain members that was chosen by FDA to pilot data architecture systems for tracking products. The Drug Supply Chain Security Act (DSCSA)...
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    Long-awaited ICH continuous manufacturing guideline coming soon

    The International Council for Harmonization (ICH) Q13 guideline on continuous manufacturing is expected to be released for public comment soon, as the US pharmaceutical industry continues slow but steady adoption of this mode of manufacturing.   Cyrus Agarabi, a reviewer in FDA’s Office of Biotechnology Products in the Office of Pharmaceutical Quality, updated attendees on the status of the ICH Q13 guideline at the 14 July CMC Strategy Forum sponsored by the California...
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    Upcoming ICH guidelines should ease post-approval changes for analytical methods

    Two forthcoming guidelines from the International Council on Harmonization (ICH) should make it easier to switch analytical methods for testing medicines post-approval and better manage lifecycle changes, said regulators and industry officials speaking Wednesday at the CMC Strategy Forum sponsored by the California Separation Science Society (CASSS).   At the meeting, an official from the European Medicines Agency (EMA) and industry representatives provided a glimpse o...
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    FDA sees different tactics were successful in established conditions pilot

    Manufacturers leveraged diverse approaches to defining established conditions (ECs), a core tenet of the International Council for Harmonization’s (ICH) Q12 guideline for managing post-approval changes, in its recently concluded EC pilot program, said US Food and Drug Administration (FDA) officials at a recent meeting.   Christopher Downey, review chief in FDA’s Office of Biotechnology Products in the drug center’s Office of Pharmaceutical Quality, spoke of some of the...
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    EMA guidelines highlight changes to IMPs triggering notification to regulators

    The European Medicines Agency (EMA) on 1 July released for public consultation two draft guidelines to help sponsors of investigational medicinal products (IMPs) for new drugs and biologics decide whether manufacturing changes are considered a “substantial modification” needing prior approval.   These guidelines are connected to the EU regulation No. 536/2014 which came into force on 20 June 2014. The regulation defines a “substantial modification” as any change to a...
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    FDA calls for new warning labels on hydroxyethyl starch products

    The US Food and Drug Administration (FDA) on Thursday says it is requiring new safety warnings for hydroxyethyl starch (HES) products in light of reports of death, kidney injury and excessive bleeding associated with these products.   HES treatments are used to stabilize patients experiencing severe blood loss. The announcement follows up on an FDA safety review of these products from randomized clinical trials, meta-analyses, and observational studies. Through this re...
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    Recon: Biden and Democrats face dilemma on vaccine mandates; EU to discuss joint recognition of vaccine certificates with Russia

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA narrows patient group for Biogen's Alzheimer's drug ( Reuters ) Alzheimer antibody rush begins, as efficacy concerns remain ( Nature ) AstraZeneca-Amgen drug gets FDA speedy review as asthma treatment ( Reuters ) Death rates are declining for many common cancers in the U.S., report finds ( STAT ) HHS head: 'Absolutely the government's business' to kn...
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    EMA updates Q&A on nitrosamine assessment and testing

    The European Medicines Agency (EMA) has published an updated “question and answer” guidance describing how manufacturers should assess the risk of nitrosamine impurities in drug products and how to test products for these impurities.   It contains minor revisions from a previous version published last year. (RELATED: EMA addresses risk evaluation, mitigation for nitrosamines , Regulatory Focus, 6 August 2020) . EMA wants marketing authorization holders (MAHs) ...
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    DIA: Woodcock, other top officials tout benefits of master protocols, want momentum to continue post-COVID

    Top officials from the US Food and Drug Administration (FDA) exhort the benefits of master protocols and hope the momentum of using these protocols continues in the post-COVID-19 era. Officials also say the pandemic has not dampened the enthusiasm for gene therapy development as the agency continues to receive a healthy number of investigational new drug applications (INDs) for these therapies.   These were some of the learnings imparted by agency officials in discussi...