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    21st Century Cures Act and Acceleration of Device Approval

    • 17 October 2018
    This article discusses two critical provisions of the law meant to accelerate FDA approval of medical devices. It explains the benefits of the provisions, which have been criticized by consumer advocates in the past.
  • ReconRecon

    Recon: Novartis to Buy Endocyte for $2.1B

    • 18 October 2018
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
  • Regulatory NewsRegulatory News

    FDA Looks to Harmonize Generic Drug Scientific and Technical Standards via ICH

    • 18 October 2018
    The US Food and Drug Administration (FDA) revealed Thursday that it’s offering a proposal to the International Council on Harmonisation (ICH) to better harmonize scientific and technical standards for generic drugs.
     
  • RAPS' LatestRAPS' Latest

    Making the Switch to Advertising and Promotion: My First 90 Days

    • 18 October 2018
    After more than three decades of working directly with the development, approval or clearance and subsequent commercialization of medical technologies, Steve Jwanouskos made the switch to advertising and promotion regulatory review. He found he was able to make the transition more smoothly and effectively by following a few simple steps in his first 90 days on the job.
  • Regulatory NewsRegulatory News

    Democrats Grill Drugmakers Over Tax Savings

    • 17 October 2018
    In letters to the CEOs of five top US drugmakers, 16 House Democrats question the companies’ actions on pricing, investment in research and development, employment, stock buybacks and executive compensation in light of tax savings as a result of the 2017 Tax Cuts and Jobs Act (TCJA).
  • Regulatory NewsRegulatory News

    EU Releases Working Plan to Implement MDR/IVDR

    • 17 October 2018

    The European Commission (EC) issued a working plan on Wednesday for the implementation of the new EU medical device and in vitro diagnostics regulations (MDR and IVDR).

  • Regulatory NewsRegulatory News

    Cybersecurity: FDA Spells Out Updated Premarket Policies

    • 17 October 2018
    With its first guidance in the device space in FY 2019, the US Food and Drug Administration (FDA) unveiled an awaited draft guidance on Wednesday to clarify the agency’s cybersecurity expectations from a premarket perspective.
  • Regulatory NewsRegulatory News

    CDRH Finalizes Classifications on Herpes Virus IVD, Limb Tremor Stimulator

    • 17 October 2018
    In final orders issued Tuesday, the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) classified two new device types into class II (special controls).

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Recon
Recon: Novartis to Buy Endocyte for $2.1B
18 October 2018
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: Minnesota AG Sues Insulin Makers; Express Scripts Covers Amgen, Lilly Migrane Drugs, Excludes Teva’s Ajovy Recon: FDA Approves Pfizer’s Talazoparib; Humira Biosimilars Launch in Europe Recon: Alnylam Won’t Seek Accelerated Approval for Second RNAi Drug; Roche Expands SQZ Cell Therapy Pact
Regulatory News
EU Regulatory Roundup: MHRA Starts Sharing Intel With India to Curb Imports of Unlicensed Drugs
18 October 2018
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
 
CDRH Issues Final Orders on 6 Medical Device Classifications Manufacturers Not Ready for November DSCSA Deadline, Study Finds EMA Announces Pharmacovigilance Fee Increase
Feature Articles
21st Century Cures Act and Acceleration of Device Approval
17 October 2018
This article discusses two critical provisions of the law meant to accelerate FDA approval of medical devices. It explains the benefits of the provisions, which have been criticized by consumer advocates in the past.
Benefit-Risk Management, Global Advertising, Promotion and Labeling Regulations and Regulatory Intelligence Regulatory Considerations and Best Practices for Promoting an Accelerated Approval Product Optimize Labeling and Advertising Outcomes through Targeted Subject-Matter Expertise
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
09 October 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.

RAPS' Latest
Making the Switch to Advertising and Promotion: My First 90 Days
18 October 2018
After more than three decades of working directly with the development, approval or clearance and subsequent commercialization of medical technologies, Steve Jwanouskos made the switch to advertising and promotion regulatory review. He found he was able to make the transition more smoothly and effectively by following a few simple steps in his first 90 days on the job.
Looking Back at the 2018 Regulatory Convergence: the Newsworthy and Noteworthy RAPS Releases Results of Compensation Survey of Regulatory Professionals RAPS Introduces Pharmaceutical- and Medical Device-Focused Regulatory Affairs Certifications (RACs)
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