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    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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    Japan's Conditional Approval Pathway for Regenerative Medicines

    • 24 May 2018

    This article discusses the history, reasoning, legal decisions and subsequent regulatory requirements behind Japan's bid to become a world leader in regenerative medicine. The authors outline the process for seeking new regenerative product approvals through an accelerated regulatory pathway and spell out the oversight role played by Japan's regulatory authorities to enable new regenerative, cell-based therapies to be made available to the public in Japan as soon as possible, but with assurances of safety and efficacy.

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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
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
     

  • Recon: FDA Puts CRISPR Trial on Hold

    • 31 May 2018
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
     
Regulatory Focus ArticlesRSS 2.0
Recon
Recon: Teva Drops Chronic Cluster Headache Study
15 June 2018
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
Recon: Mylan Braces for FDA to Reject its Advair Copy for the Second Time Recon: J&J to Sell LifeScan Diabetes Unit in $2.1B Deal Recon: Eli Lilly, AstraZeneca Scrap Two Alzheimer's Drug Trials
Regulatory 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.
FDA Answers Questions on Coding of IVDs Technical Standards for Electronic Submissions: FDA Opens Public Consultation FDA Adopts ICH Guideline on Nonclinical Evaluation for Anticancer Drugs
Feature Articles
Regulatory Challenges for Artificial Intelligence Applications in Healthcare
15 June 2018

This article addresses regulatory challenges associated with using artificial intelligence in healthcare. The authors explore challenges in regulating “digital health” and review various pathways to gain regulatory approval for artificial intelligence applications to be employed in healthcare.

Unifying the Clinical Landscape to Drive Efficiency and Compliance Drug Reform, Expedited Pathways, Regenerative Medicine and Gene Therapy Accelerated Pathways in the US and EU for Expedited Marketing Authorization Approval
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
30 April 2018
Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.
Regulatory Explainer: Everything You Need to Know About Biosimilars Regulatory Explainer: FDA User Fee Reauthorizations From 2018 to 2022 Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA
About Regulatory Focus

Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.

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