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  • Regulatory NewsRegulatory News

    Former FDA Commissioners Make the Case for an Independent Regulatory Agency

    • 19 October 2018

    At a plenary session at the American University in Washington, DC four former US Food and Drug Administration (FDA) commissioners argued for FDA to be an independent regulatory agency.

  • Regulatory NewsRegulatory News

    FDA Tweaks List of Recognized Consensus Standards for Devices

    • 19 October 2018
    A total of about 90 consensus standards used for device premarket reviews and other device regulatory requirements will undergo certain modifications set forth Friday in a notice from the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).
  • Regulatory NewsRegulatory News

    Health Canada Puts Brakes on SaMD Draft Guidance

    • 19 October 2018
    A scientific advisory panel on software as a medical device (SaMD) convened in January by Health Canada caused the agency to hit the brakes on a draft guidance document.
     
  • Regulatory NewsRegulatory News

    EMA’s CHMP Recommends Six Medicines for Approval

    • 19 October 2018
    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced the recommendation of six medicines for approval, including two orphan medicines, as well as three extensions of indications and a new vice-chair.
     
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    Feature ArticlesFeature 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.
  • Regulatory NewsRegulatory News

    CDRH Issues Final Orders on 6 Medical Device Classifications

    • 18 October 2018
    A set of final orders issued by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) on Thursday established new classifications for six device types.
     
  • Regulatory NewsRegulatory News

    Manufacturers Not Ready for November DSCSA Deadline, Study Finds

    • 18 October 2018
    A new study found that pharmaceutical manufacturers are woefully behind in meeting a 27 November deadline, as nearly 80% of pharmaceutical packages still do not have a readable barcode with all four required data elements necessary to meet the requirements of the Drug Supply Chain Security Act (DSCSA).
     
  • Regulatory NewsRegulatory News

    EMA Announces Pharmacovigilance Fee Increase

    • 18 October 2018
    Pharmacovigilance fees payable to the European Medicines Agency (EMA) were increased by 1.7% on Thursday to account for inflation in 2017.
  • 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).

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Recon
Recon: Vertex Touts Positive Preliminary Results for Three Drug CF Combo; AbbVie CFO to Retire
19 October 2018
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: Novartis to Buy Endocyte for $2.1B 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
Regulatory News
Former FDA Commissioners Make the Case for an Independent Regulatory Agency
19 October 2018

At a plenary session at the American University in Washington, DC four former US Food and Drug Administration (FDA) commissioners argued for FDA to be an independent regulatory agency.

FDA Tweaks List of Recognized Consensus Standards for Devices Health Canada Puts Brakes on SaMD Draft Guidance EMA’s CHMP Recommends Six Medicines for Approval
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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