• Regulatory NewsRegulatory News

    Official encourages ATMP sponsors to consult toolbox guidance to avoid PRIME derailments

    An EU official advised manufacturers of advanced therapy medicinal products (ATMPs) to consult the European Medicines Agency’s (EMA) recently issued “toolbox” guidance to avoid having products rejected from being eligible for accelerated review under the PRIME program for quality-related deficiencies.   Barbara Bonamassa, a reviewer with the Italian Medicines Agency (AIFA), offered an update on some of the EU’s ongoing activities to expedite the development of ATMP the...
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    Recon: FDA staff find Pfizer, Moderna vaccines safe for children; Rune Labs gets clearance to track Parkinson’s symptoms with Apple Watch

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer COVID vaccines safe and effective for small children, FDA staff say ( Reuters ) ( NYTimes ) U.S. FDA staff says Moderna COVID vaccine effective and safe for children ( Reuters ) ( Politico ) FDA requires disclosure of suicide risk for anti-baldness drug ( Reuters ) Rune Labs gets FDA clearance to use Apple Watch to track Parkinson's symptoms ( Reuters )...
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    FDA and EMA mostly align on GCP inspection deficiencies, study finds

    A study conducted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) found that the agencies are identifying the same types of deficiencies in joint good clinical practice (GCP) inspections with respect to protocol compliance, documentation deviations, and human subject protections.   The paper follows a mutual transatlantic cooperation on GCPs between the regulators that went into effect on 1 September 2009. Under the program, regulators ...
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    EMA releases final guideline on antibacterial drug development

    The European Medicines Agency (EMA) has issued a final guideline on evaluating antibacterial medicines that is globally aligned with guidance from other regulators.   EMA said the document addresses a “pressing need for new antibacterial agents suitable for treating infections in patients with few remaining therapeutic options.”   The agency announced that antimicrobial resistance poses a “global threat” and is responsible for an estimated 33,000 deaths per yea...
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    FDA, EMA tout benefits of parallel scientific advice program

    Regulators described how the parallel scientific advice (PSA) program offered by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) saves sponsors time and resources by bringing both health authorities to the table to hammer out solutions to complex scientific issues arising from their drug development packages at a 16 March webinar held by FDA’s Small Business and Industry Assistance (SBIA) program.   The goal of the PSA program is to ...
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    EU adopts common standard for electronic product information

    European regulators on Tuesday announced the adoption of a common electronic product information (ePI) standard for human medicines that can be accessed by users and healthcare providers alike.   ePI is beneficial because it can be updated and disseminated to stakeholders immediately, without having to wait for new information to be formatted and printed, European Medicines Agency officials said in a statement . EMA released the standard along with the European Commis...
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    EMA offers more clarity on controlling multiple nitrosamines

    The European Medicines Agency (EMA) last week issued a revised question and answer guidance describing how marketing authorization holders (MAHs) should identify and control the risks of nitrosamines identified in drug products and active pharmaceutical ingredients (APIs).   The guidance contains minor revisions from a previous revision from October 2021. The revised guidance includes a new nitrosamine that should be tested: N-nitrosodipropylamine (NDPA) with a daily...
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    Recon: Elizabeth Holmes found guilty of four counts of fraud; Another big Paxlovid deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US More than 1 million Americans were diagnosed with COVID over the long holiday weekend ( NPR ) ( Reuters ) Elizabeth Holmes is found guilty of four counts of fraud ( NYT ) ( POLITICO ) The Epic Rise and Fall of Elizabeth Holmes ( NYT ) Pfizer carries pandemic momentum into 2022, scoring another huge Paxlovid deal with the US ( Fierce ) CDER, CBER Approve Total...
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    Euro Roundup: EMA reflects on a decade of collaboration with HCPs, recommends Janssen COVID booster

    The European Medicines Agency (EMA) recently released a report that reflected on a decade of implementing a framework to better work with doctors, pharmacists, and nurses in the EU.   As of December 2021, there are now 38 eligible organizations working with the agency in a variety of practice areas. The framework is designed for EMA to access a network of independent experts in clinical practice who can advise on real-world experience with drug development, benefit-ris...
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    Recon: Califf's Senate hearing; Moderna, Amgen pull out of JPM

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Former FDA commissioners endorse Califf as head of agency, citing urgency of addressing omicron ( WaPo ) Califf goes to Congress ( POLITICO ) Moderna, Amgen among biotech heavyweights pulling out of JPM conference over Covid concerns ( STAT ) US FDA’s Woodcock Sees Clinical Trial Reform Coming, But ‘Not Wholly Optimistic’ ( Pink Sheet ) Pfizer says its Co...
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    ICMRA, WHO take stock of regulatory flexibilities

    A global regulatory group is mapping out a strategy for regulatory alignment as countries around the world plan their responses in the face of the Omicron variant of SARS-CoV-2, the virus that causes COVID-19.   The International Coalition of Medicines Regulatory Authorities (ICMRA) met on the first two days of December to discuss a host of regulatory challenges. Thirteen World Health Organization (WHO) and EC officials joined representatives from ICMRA’s 24 health aut...
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    New reports address generics pricing, innovation in the EU

    A European generics trade association is calling for relaxation of “extreme cost containment policies” against generic medicines, asserting that such measures are counterproductive and may endanger the supply chain through consolidation of production and withdrawal or products from the market.   “The European Commission has collected a growing body of evidence showing that extreme cost containment policies applied to generic medicines are counterproductive, driving ind...