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    House subcommittee moves FDA $3.6B budget forward

    Lawmakers in the House Appropriations agriculture subcommittee have sent their FY 2023 budget package that includes funding for the US Food and Drug Administration (FDA) to the full committee, proposing $3.6 billion in discretionary funding for the agency to address the opioid crisis, further research on amyotrophic lateral sclerosis (ALS), foreign inspections and more.   On 15 June the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies ...
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    Clinical trial diversity: Sponsors seek clarity on data sources, timing

    Drugmakers and clinician organizations praised the US Food and Drug Administration’s (FDA) recent draft guidance containing recommendations on developing a Race and Ethnicity Diversity Plan to improve enrollment of underrepresented racial and ethnic groups in clinical trials. But in public comments, they also called for greater details on the types of data that should be used to assess adequate enrollment of these populations, how these diversity plans should be applied to...
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    Former FDA officials call for more transparency for drug approvals

    The US Food and Drug Administration (FDA) needs to take a more proactive approach in combatting misinformation and communicating decisions to the public when approving drugs, especially when the decision goes against the recommendations of its advisory committees. Not doing so will continue to undermine the public’s trust in the agency, said a panel of former FDA commissioners and others at the Food and Drug Law Institute (FDLI) annual conference on Tuesday.   Califf ad...
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    Recon: EMA starts rolling review of Pfizer-BioNTech variant vaccine; Pfizer halts Paxlovid study enrollment for lower-risk population

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Advisers Review Pfizer, Moderna Covid-19 Vaccines in Young Children ( WSJ ) ( STAT ) ( Reuters ) US pivots to ‘harm reduction’ after 107,000 overdose deaths last year ( FT ) Briefing docs for Acadia's Alzheimer's-related psychosis resubmission reveal an undecided FDA ( Endpoints ) Bristol Myers asks Supreme Court to revive $1.2 bln cancer-drug patent win (...
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    Senate HELP sends user fee reauthorization bill to floor vote

    The US Senate Health, Energy, Labor and Pensions (HELP) committee advanced a bill that would reauthorize the Food and Drug Administration (FDA) to collect medical product user fees. It differs significantly from a sister bill recently passed in the House, meaning it would need to be reconciled in a conference if it is approved by the full Senate.   In a 13 to 9 vote, the HELP committee approved the Food and Drug Administration Safety and Landmark Advancements (FDASL...
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    VRBPAC unanimously backs Moderna vaccine for children 6 and up

    The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend Moderna’s COVID-19 vaccine as a two-dose series for emergency use authorization (EUA) in children 6 years and older.   The committee met on Tuesday to discuss Moderna’s COVID-19 vaccine EUA request to include children and adolescents 6 years through 17 years of age. Moderna sought an EUA for a two-dose primary series for adoles...
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    Recon: FDA approves Lilly’s alopecia drug; EU states pressure Pfizer to cut unneeded COVID vaccine supplies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA advisers weigh Moderna COVID vaccine heart risk for young men ( Reuters ) FDA Advisers Considering Moderna’s Covid-19 Vaccine for Ages 6 to 17 ( WSJ ) Alnylam wins FDA approval of rare disease drug in step toward profitability ( BioPharmaDive ) Amylyx's ALS drug would be more cost effective if priced around $170,000, pricing watchdog says ( Reuters ) ...
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    Asia-Pacific Roundup: PMDA outlines changes to project focused on medicine use in pregnancy

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has shared details of changes to a system for promoting the proper use of drugs for pregnant and breastfeeding women. The system went live last month to support the creation of a registry and the digitization of applications.   Officials created the Japan Drug Information Institute in Pregnancy (JDIIP) in 2005 to collect and review the latest evidence on the effects of medicines on mothers and fetuses. Using the...
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    FDA should step in to help spur AI/ML standards: Expert

    The US Food and Drug Administration (FDA) should support the burgeoning integration of artificial intelligence and machine learning (AI/ML) in medical devices by encouraging the development of new standards and setting deadlines for their implementation.   That’s according to Brad Thompson, a regulatory attorney at Epstein, Becker and Green. Thompson spoke with Regulatory Focus on the state of AI/ML and what can be done to help move the regulatory needle forward. Whi...
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    Back to the drawing board for FDA’s revised quality metrics plan?

    The US Food and Drug Administration’s (FDA) revised plan to collect quality metrics data from manufacturers drew criticism from one major pharmaceutical industry group on the metrics the agency is proposing, as well as its methods for developing the program. Others complained that the proposed program lacks focus, while two industry groups also expressed serious misgivings about the purpose of the overall program.   Yet on a positive note, one industry group and major ...
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    MDCG urges manufacturers to use MDR transition period wisely

    The European Commission’s Medical Device Coordination Group (MDCG) on Monday said that manufacturers should start preparing now to ensure “timely compliance” with the Medical Device Regulations (MDR) by the time the regulation is fully applicable on 27 May 2024. Devices not certified by this date will no longer have access to the EU market, except in rare circumstances discussed in the notice.   MDCG reiterated that “to ensure that devices can continue to be placed o...
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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 )...