• 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.
  • Regulatory NewsRegulatory News

    Technical Standards for Electronic Submissions: FDA Opens Public Consultation

    • 15 June 2018
    The US Food and Drug Administration (FDA) on Friday launched a public consultation on its publication of technical specifications for electronic submissions for premarket drug and biologics submissions.
  • Regulatory NewsRegulatory News

    FDA Adopts ICH Guideline on Nonclinical Evaluation for Anticancer Drugs

    • 15 June 2018
    With the publication of a final guidance on Friday, the US Food and Drug Administration (FDA) has adopted the International Council for Harmonization's (ICH) questions and answers guideline on the nonclinical evaluation of drugs intended to treat cancer.
     

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  • 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.
     
  • 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    In addition to new draft guidance documents on gene therapy-related issues, the US Food and Drug Administration (FDA) will also release guidance on the clinical development of gene and cell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
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  • 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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