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BioWorld - Sunday, May 22, 2022

FDA

Home » Topics » Regulatory » FDA
  • May 20, 2022
    By Lee Landenberger

    Foghorn’s phase I in AML on a partial clinical hold

    In the wake of a patient’s death, the U.S. FDA has placed a partial clinical hold on Foghorn Therapeutics Inc.’s phase I study of FHD-286 in treating relapsed and/or refractory acute myelogenous leukemia (r/r AML) and myelodysplastic syndrome.
  • May 19, 2022

    US FDA churns out more guidances, updates

    Another spate of U.S. FDA guidances for prescription drug manufacturers includes updates for carton labeling, product-specific advice and recommendations on mitigating potential drug shortages.
  • 05 17 labcorp a1c kit blood collection stick
    May 17, 2022
    By Annette Boyle

    Labcorp expands DTC business with EUA for COVID-19, influenza and RSV test, launch of diabetes screening test

    The pandemic exponentially amplified the move to more patient-driven health care with at-home monitoring, wearable medical devices and telemedicine. Testing has arguably seen the greatest shift, led by emergency use authorizations (EUA) for dozens of rapid tests for SARS-CoV-2. Laboratory Corp. of American Holdings Inc. (Labcorp) stands to benefit even more from the trend with an EUA for an over-the-counter multiplex respiratory virus test and the launch of an at-home collection kit for testing hemoglobin A1c (HbA1c) this week.
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Blog Posts

  • International standards iso
    Feb. 3, 2022
    By Mark McCarty

    Goldilocks or bust: The FDA’s regulatory harmonization dilemma

  • 08 13 blog fda
    Aug. 13, 2021
    By Mark McCarty

    Forward to the past: The FDA commissioner dilemma

  • Health care politics illustration
    Aug. 26, 2020
    By Mari Serebrov

    U.S. politicking threatens public trust in the FDA and CDC

  • Dec. 5, 2013
    By Mark McCarty

    Trust in government: 23 more reasons for suspicions

  • May 29, 2013
    By Jim Stommen

    Med-tech community wary, but at the same time optimistic about the future of the sector

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Authors

  • Holland Johnson
  • Mark McCarty
  • Omar Ford
  • Amanda Pedersen
  • Jim Stommen
  • Randy Osborne
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