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    FDA’s Oncology Clinical Trial Makeover

    • 12 February 2019
    This article provides an overview of new FDA guidances related to oncology drug development and a review of pilot programs aiding faster access to new, innovative treatments without increasing risk to patients.
  • Regulatory NewsRegulatory News

    EMA on Brexit: Risk for Drug Shortages Decreases

    • 22 March 2019
    As the UK and EU agreed to extend the Brexit deadline, the European Medicines Agency’s (EMA) Management Board said following its first meeting in Amsterdam that the prospect for centrally authorized products to be at risk of shortage “continues to decrease.”
     
  • Regulatory NewsRegulatory News

    Public Citizen, FDA Advisor Call for Moratorium on Opioid Approvals

    • 21 March 2019
    Nonprofit advocacy group Public Citizen on Thursday filed a citizen petition calling for the US Food and Drug Administration (FDA) to impose a moratorium on approving new or reformulated opioids until the agency implements recommendations from a 2017 report by the National Academies of Science, Engineering and Medicine.
  • Regulatory NewsRegulatory News

    Reorganization of FDA’s Office of the Commissioner to Begin Soon

    • 21 March 2019
    Beginning 31 March, the US Food and Drug Administration’s (FDA) Office of the Commissioner will reorganize and make several changes to various offices within FDA, including the Office of New Drugs (OND).
     
  • Regulatory NewsRegulatory News

    UK Offers More No-Deal Brexit Guidance on Clinical Trials, PIPs

    • 20 March 2019
    With a glimmer of hope for a short extension to the Brexit deadline of 29 March, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is still releasing guidance in case Brexit occurs without a deal in place.
  • Regulatory NewsRegulatory News

    EMA Follows FDA Warning on Xeljanz Blood Clot Risks

    • 20 March 2019
    The European Medicines Agency (EMA) on Wednesday warned patients and healthcare professionals against exceeding the recommended dose of Pfizer’s rheumatoid arthritis (RA) drug Xeljanz (tofacitinib) due to an increased risk of blood clots forming in the lungs.
  • Regulatory NewsRegulatory News

    Breast Implant Manufacturers Draw FDA Warning Letters Over Post-Approval Studies

    • 20 March 2019
    The US Food and Drug Administration (FDA) sent warning letters this week to two breast implant manufacturers over their failures to comply with FDA’s post-approval study (PAS) requirements.
     
  • Regulatory NewsRegulatory News

    OMB Reviews Proposal to Add Prices to Pharma TV Ads

    • 20 March 2019
    The Office of Management and Budget (OMB) this week began reviewing a proposed rule that would require drug companies to include list prices in direct-to-consumer television advertisements.
     

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  • FDA Rescinds Two Breakthrough Therapy Designations

    • 08 March 2019
    In a rare move, the US Food and Drug Administration (FDA) this month has rescinded two companies’ breakthrough therapy designations (BTDs) because of clinical trial data.
     

  • Gottlieb to Resign as FDA Commissioner

    • 05 March 2019
    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb unexpectedly announced Tuesday that he will resign in one month.
     

  • EU Publishes First Corrigenda for MDR, IVDR

    • 20 March 2019
    As part of an effort to fix the mistakes, inconsistencies and slightly correct the EU’s Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR), the Council of the European Union this week released two corrigenda.
     

  • Novartis Sues Janssen Over False Advertisements for Psoriasis Drug

    • 04 March 2019
    Novartis filed a lawsuit on Friday in DC federal court claiming that Janssen has presented data on its severe plaque psoriasis drug in a false and misleading way in at least two presentations at conferences over the past several months.
     
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Recon
Recon: Democrats Push Back Against 10-Year Biologic Exclusivity in Nafta Rewrite; Snapchat Looks to Woo Pharma Advertisers
22 March 2019
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: Democrats Push Back Against 10-Year Biologic Exclusivity in Nafta Rewrite; Snapchat Looks to Woo Pharma Advertisers Recon: Biogen, Eisai Scrap Two Late-Stage Alzheimer’s Studies Recon: Pfizer Buys Stake in French Gene Therapy Developer Vivet
Regulatory News
FDA, DHS Alert to Cybersecurity Flaws Affecting Medtronic Cardiac Devices, Programmers, Monitors
22 March 2019
Hundreds of thousands of units of Medtronic implantable cardiac devices, programmers and home monitors are vulnerable to cybersecurity incidents, according to two US federal government notices.
FDA, DHS Alert to Cybersecurity Flaws Affecting Medtronic Cardiac Devices, Programmers, Monitors Natural History Studies for Rare Diseases: FDA Drafts Guidance EU MDR/IVDR Coordination Group Urges Exemption Clarification
Feature Articles
Planning and Submission Considerations for Animal Drugs
14 March 2019
This article discusses the comprehensive planning and streamlining submission considerations by animal health companies that can decrease development cost and registration time for animal drugs.
Planning and Submission Considerations for Animal Drugs The Chinese Pharmaceutical Market Today China’s New, Faster Marketing Authorization Approval Program
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
18 March 2019
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 FDA’s Priority Review Vouchers Regulatory Explainer: Everything You Need to Know About Biosimilars Regulatory Explainer: FDA User Fee Reauthorizations From 2018 to 2022
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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.

RAPS' Latest
RAPS Launches Europe Conference as European Regulatory Environment for Medical Products Faces Sweeping Changes
05 March 2019
RAPS will hold its inaugural RAPS Regulatory Conference – Europe 2019 in Brussels as the European regulatory environment for medicines, medical devices and in vitro diagnostics is undergoing major changes.
RAPS Launches Europe Conference as European Regulatory Environment for Medical Products Faces Sweeping Changes Focus on: Jethro Ekuta RAPS Opens Board of Directors Nominations
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