• Regulatory NewsRegulatory News

    FDA to Begin Updating Generic Cancer Drug Labels With New Congressional Funding

    • 18 June 2018
    The US Food and Drug Administration (FDA) on Monday announced it would use new budget funding to update generic drug labels and will begin with cancer drugs, among other initiatives.
  • Regulatory NewsRegulatory News

    6-Month Delay of Common Rule Changes Explained

    • 18 June 2018
    The Department of Health and Human Services (HHS) and other federal departments and agencies on Monday announced a six-month delay to the federal policy on the protection of human subjects, which is better known as the “Common Rule.”
  • Regulatory NewsRegulatory News

    Combination Products: FDA Updates Inter-Center Consult Request Manual

    • 15 June 2018
    A staff manual detailing the US Food and Drug Administration's (FDA) internal policies and processes for handling inter-center consult requests (ICCR) for combination product reviews has been updated for the first time in 14 years to reflect changes to the process and feedback from external and internal surveys.
  • Regulatory NewsRegulatory News

    FDA Answers Questions on Coding of IVDs

    • 15 June 2018
    In an effort to standardize the information gathered via in vitro diagnostic (IVD) tests, the US Food and Drug Administration issued guidance Friday providing clarifications on the distribution of codes used by manufacturers.

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  • Gottlieb: FDA Prepping for Push of New Gene and Cell Therapies

    • 22 May 2018
    In addition to new draft guidance documents on gene therapy-related issues, the US Food and Drug Administration (FDA) will also release guidance on the clinical development of gene and cell therapies, FDA Commissioner Scott Gottlieb said at the Alliance for Regenerative Medicine's annual board meeting on Tuesday.
  • Recon: In Biotech, $6 Billion Can Vanish Quickly

    • 05 June 2018
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
     
  • Bioanalytical Method Validation: FDA Finalizes Guidance From 2013

    • 21 May 2018
    The US Food and Drug Administration (FDA) on Monday finalized guidance revised in 2013 to help companies validate bioanalytical methods used in human clinical pharmacology, bioavailability (BA) and bioequivalence (BE) studies that require pharmacokinetic, toxicokinetic or biomarker concentration evaluation.
     
  • Recon: FDA Puts CRISPR Trial on Hold

    • 31 May 2018
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
     
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