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    EMA Extends Valsartan Review to Include Four More Active Substances

    • 21 September 2018
    The European Medicines Agency (EMA) announced Friday it has extended its review of two impurities classified as probable human carcinogens from its initial valsartan focus to include medicines containing four other “sartans.”
  • Regulatory NewsRegulatory News

    DITTA Calls on FDA, Health Canada to Take Up Proposed IMDRF Work on Cybersecurity

    • 21 September 2018
    A new work item on cybersecurity was proposed at the International Medical Device Regulators Forum (IMDRF) management committee hearing this week in Beijing, China by the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA).
  • Regulatory NewsRegulatory News

    CHMP Backs 13 New Medicines, Maintains Negative Opinion of Sarepta’s Exondys

    • 21 September 2018
    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended thirteen new medicines for EU approval and reaffirmed its negative opinion of Sarepta Therapeutics’ Duchenne muscular dystrophy drug Exondys (eteplirsen).
  • Regulatory NewsRegulatory News

    FTC Charges First Marketer of Intravenous Products

    • 21 September 2018
    The Federal Trade Commission (FTC) has, for the first time, charged a marketer and seller of intravenously injected therapy products, known as iV Cocktails, with making a range of “deceptive and unsupported health claims” about their ability to treat serious diseases.
     
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    Complying With the new EU IVDR

    • 22 August 2018

    This article discusses processes and plans that need to be developed by In Vitro Diagnostic (IVD) companies to address the new EU In Vitro Diagnostic Regulations (IVDRs) in advance of their coming into full force in 2022.

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Recon
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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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Regulatory News
EMA Extends Valsartan Review to Include Four More Active Substances
21 September 2018
The European Medicines Agency (EMA) announced Friday it has extended its review of two impurities classified as probable human carcinogens from its initial valsartan focus to include medicines containing four other “sartans.”
DITTA Calls on FDA, Health Canada to Take Up Proposed IMDRF Work on Cybersecurity CHMP Backs 13 New Medicines, Maintains Negative Opinion of Sarepta’s Exondys FTC Charges First Marketer of Intravenous Products
Feature Articles
Clarifying FDA’s Off-Label Promotion Efforts
19 September 2018

This article discusses off-label promotions and subsequent changes in related FDA guidances derived from the agency’s approaches to two First Amendment cases and recently enacted state laws regarding off-label communication. 

Canadian Drug Advertising Regulations Pregnancy and Lactation Labeling Rule: Strategies for Updating Prescription Drug Labels for Compliance Benefit-Risk Management: the Role of Patient Input
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
23 August 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.
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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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