• Regulatory NewsRegulatory News

    FDA caught up on domestic preapproval inspections, foreign inspections still a challenge

    The US Food and Drug Administration (FDA) eliminated its backlog of overdue domestic preapproval inspections, yet such progress has been stunted at the international level as getting to sites in China has remained a challenge amid the country’s COVID-19 pandemic restrictions. So asserted Patrizia Cavazzoni, the director of FDA’s Center for Drug Evaluation and Research (CDER), who provided an update on the center’s activities and priorities for 2022 at the Food and Drug ...
  • ReconRecon

    Recon: Pfizer to buy 8.1% stake in Valneva, Merck explores Seagen buyout

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US COVID vaccine rollout for US children close after CDC panel vote ( Reuters ) Lawmakers ask GAO to probe pharmacy benefit managers over their role in drug pricing ( STAT ) Comparing the Pfizer and Moderna Covid vaccines for young children ( STAT ) Merck Explores Purchase of Biotech Seagen ( WSJ ) FDA advisors mostly agree that Acadia’s Nuplazid isn't effective...
  • This Week at FDAThis Week at FDA

    This Week at FDA: FDA authorizes COVID vaccines for youngest children; Congress holds budget, pandemic hearings

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. It was budget week on the Hill and with that, we saw a number of hearings related to the FY2023 budget and pandemic funding. The biggest news of the week is FDA's  authorization of two mRNA COVID-19 vaccines for children as young as 6 months of age. The authorizations comes after months...
  • Regulatory NewsRegulatory News

    FDA authorizes Pfizer, Moderna vaccines for youngest children

    The US Food and Drug Administration (FDA) on Friday authorized the emergency use of Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children as young as 6 months of age, asserting that the benefits of the vaccines outweigh the risks.   This action comes two days after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to support expanding the emergency use authorizations (EUAs). (RELATED: VRPAC recommends Pfizer, Mode...
  • Regulatory NewsRegulatory News

    CBER outlines recognition process for regenerative medicine therapy standards

    The US Food and Drug Administration (FDA) outlined its process for recognizing voluntary consensus standards (VCS) related to regenerative medicine therapies in a new draft guidance document. The draft guidance , issued 15 June 2022 by the Center for Biologics Evaluation and Research (CBER), outlines how VCS bodies and standards will be evaluated by agency staff, where these standards can be accessed, and how individuals can request recognition of a specific VCS. The g...
  • Regulatory NewsRegulatory News

    Senate HELP committee tussles over additional COVID funding

    Partisan disagreement set the tone at a 16 June hearing of the Senate Health, Education, Labor and Pensions (HELP) Committee, where Democrats on the committee warned lack of additional COVID-19 funding would set back the progress made in managing the crisis while Republicans questioned whether the administration had spent the funding it already received wisely.   At the hearing , commmitte members heard testimony from federal officials including Rochelle Walensky, dir...
  • Regulatory NewsRegulatory News

    FDA takes a step forward for machine learning with quantitative imaging guidance

    The US Food and Drug Administration finalized guidance on what to consider when using quantitative imaging algorithms in radiological device submissions. While most imaging diagnostics rely on qualitative readings by trained physicians, imaging devices increasingly rely on quantitative imaging results using machine learning.   On 15 June, FDA finalized its Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions guidance ...
  • RoundupsRoundups

    Euro Roundup: Generic manufacturers ask EU for inflation help

    Leaders at generic drug manufacturers including Sandoz, Teva and Viatris have written to European Union authorities to request actions that enable them to cope with “rampant cost inflation.”   In a letter published by the trade group Medicines for Europe, generic drug manufacturers make the case that the combination of inflation and “policies that continuously lower prices” is unsustainable. Inflation in Europe is above 7% for the first time in decades and the generic ...
  • ReconRecon

    Recon: Moderna to study COVID vaccine in babies 3 to 6 months of age; Walgreens enters clinical trial business

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US FDA Commissioner Admonishes Health Care Stakeholders To Know Agency Better, Help More ( MedtechInsight ) Moderna to Study Its Covid-19 Vaccine in Babies as Young as 3 Months ( WSJ ) FDA Panel Recommends Pfizer and Moderna Vaccines for Youngest Children ( NYTimes ) ( STAT ) Abbott Baby Formula Plant Again Stops Production, This Time Because of Flooding ( NYT...
  • 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...
  • Regulatory NewsRegulatory News

    VRBPAC recommends Pfizer, Moderna COVID vaccines for youngest children

    On Wednesday, the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of amending FDA’s emergency use authorization (EUA) for Moderna’s two-dose vaccine to include children 6 months through 5 years of age. The committee voted separately in favor of recommending to amend Pfizer’s EUA for its vaccine and authorize use of a three-dose vaccine for children 6 months through 4 years of age.   In a 21-0 v...
  • Regulatory NewsRegulatory News

    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 ...