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    PhRMA, AdvaMed weigh in on safety reporting draft guidance

    Two industry trade associations and a pharmaceutical company are asking for some adjustments and clarification on the US Food and Drug Administration’s (FDA’s) draft guidance on safety reporting or investigational drugs and devices. The comment period on the guidance closed at the end of November.   FDA’s draft guidance includes details of how the agency believes investigators should report serious and non-serious adverse events in investigational new drug applicatio...
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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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    Exclusive accelerated approval drugs comprise ‘relatively small share’ of Medicare spending

    Policymakers looking to rein in Medicare spending should look beyond the lens of the accelerated approval pathway, as drugs that exclusively fall under this indication make up a small percentage of overall Medicare spending, according to a recent research letter written by Benjamin N. Rome, of the Program on Regulation, Therapeutics, And Law (PORTAL) research group at Harvard Medical School and Brigham & Women’s Hospital, and colleagues.   “Medicare is spending more an...
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    FDA announces FY 2022 GDUFA science and research priorities

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) has announced its science and research priorities for fiscal year (FY) 2022 to spur the development of complex generic drugs. The priorities were prompted by public feedback the agency received at a public workshop earlier this year.   The agency also announced the availability of fellowships and funding for research activities that are aligned with these priorities.   The workshop was held i...
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    Public-private initiative expands support for NGS tests

    A key microbial genome database is being updated and expanded through a public-private partnership, as the US Food and Drug Administration (FDA) works with a health data company and an academic institution to build out the FDA-ARGOS database.   In partnership with George Washington University and Embleema, which maintains a bioinformatics platform, FDA  is conducting a year-long, $2 million project to “further improve the utility of the FDA-ARGOS database as a key tool...
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    FDA offers draft guidance for registries as RWD

    The US Food and Drug Administration (FDA) released draft guidance on the use of registries in regulatory decision making, adding another piece to the puzzle of how the agency will consider real-world data (RWD) when considering a new drug indication or assessing post-approval requirements.   The draft guidance , which was published Monday, outlines considerations for sponsors and stakeholders when proposing to design a registry or use an existing registry to support r...
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    Recon: Blueprint's $250M preclinical buy; WHO, CDC, Biden react to Omicron variant

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden says omicron variant is cause for concern but not panic ( NPR ) CDC Statement on B.1.1.529 (Omicron variant) ( CDC ) Pfizer boosts Paxlovid manufacturing capacity as Merck’s rival COVID pill hits surprise efficacy setback ( Fierce ) Opinion: Becerra needs to open up to the press ( AHCJ ) Opinion: Will Moderna Ever Learn to Share? ( MedPage Today ) Who ...
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    FDA shares research to improve dose selection in pediatric drug development

    Dose selection is a significant challenge in pediatric drug development; commonly used renal function equations can overestimate glomerular filtration rates and result in inaccurate predictions of drug elimination.   In a Regulatory Science in Action article , scientists from the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) shared findings about how adjustments to the estimated glomerular filtration rate (eGFR) equations could help ...
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    This Week at FDA: mRNA boosters for most; Blood lancets reclassified

    Welcome to our weekly digest of regulatory news from the US Food and Drug Administration (FDA), legislative updates, and other news updates we think you’ll find useful — and interesting. This week saw COVID-19 vaccine and therapy updates, the unveiling of Cures 2.0 , and lots of device updates. As usual, we welcome feedback at news@raps.org .    Friday morning, the US Food and Drug Administration (FDA) announced an expansion of the emergency use authorizations (EUA...
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    FDA could do more to enforce ClinicalTrials.gov reporting requirements

    The US Food and Drug Administration (FDA) hasn’t been notifying most clinical trial sponsors they are in violation of reporting requirements.   That’s according to results of a Freedom of Information Act (FOIA) investigation by Reshma Ramachandran, of the Yale School of Medicine in New Haven, CT, and colleagues in a recent Viewpoint published in JAMA .   In January 2017, a final rule issued by the National Institutes of Health (NIH) determining ClinicalTrials.go...
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    This Week at FDA: CDRH and Endologix leaks, OTC monograph reform, and more

    Welcome to Week 2 of This Week at FDA . We've again gathered the week’s news from (and about) FDA. Each Friday, we'll be covering agency activities and enforcement actions, filings in the  Federal Register , new guidances, legislative updates, and anything else we come across – all in one place. We hope you will find it to be your one-stop shop for FDA updates. What do you think? We’d be happy to hear your feedback at news@raps.org. The House Committee on Oversight ...
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    This Week at FDA: New proposed rules, Biocon's Form 483, and more

    We're trying something new at Regulatory Focus , with the goal of gathering the week’s news from (and about) FDA. We'll be covering agency activities and enforcement actions, filings in the Federal Register , new guidances, legislative updates, and anything else we come across – all in one place. We hope you will find it to be your one-stop-shop for FDA updates. What do you think? We’d be happy to hear your feedback at news@raps.org. News from this week One of t...