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    Feature ArticlesFeature Articles

    Regulatory and Economic Challenges for Gene Therapy Utilization

    • 17 April 2018

    This article addresses pricing and reimbursement challenges associated with clinical utilization of approved gene therapies. The authors recommend potential approaches to resolve these challenges, the implementation of which may help solve issues related to the high cost of these therapies and encourage continued innovation and further development of advanced gene therapies.

  • ReconRecon

    Recon: Rigel wins first FDA approval; Abbott shares down as device sales grow

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

    FDA Director Moves to AstraZeneca

    • 18 April 2018
    Twenty-year FDA veteran Badrul Chowdhury, most recently director of the Center for Drug Evaluation and Research’s (CDER) Division of Pulmonary, Allergy and Rheumatology Products, has taken a job this month as senior vice president at AstraZeneca.
  • Regulatory NewsRegulatory News

    FDA Plans to Ramp Up Disease-Focused Guidance

    • 17 April 2018
    FDA Commissioner Scott Gottlieb on Tuesday told a House Appropriations subcommittee that the agency plans to “sharply increase” its release of disease-focused guidance documents to help drugmakers develop new treatments.
  • Regulatory NewsRegulatory News

    7 Questions for HHS and FDA: Grassley Targets Stem Cell Clinic

    • 17 April 2018
    Sen. Charles Grassley (R-IA) late last week sent a letter to HHS and FDA leadership, requesting more information about an unproven stem cell treatment that left several patients permanently blind.

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  • FDA Proposes New Option for Device Companies to Apply for 510(k) Clearance

    • 11 April 2018
    A draft guidance the US Food and Drug Administration (FDA) revealed Wednesday sets the stage for how an existing 510(k) pathway will be expanded with the goal of providing firms greater flexibility.

  • FDA Director Moves to AstraZeneca

    • 18 April 2018
    Twenty-year FDA veteran Badrul Chowdhury, most recently director of the Center for Drug Evaluation and Research’s (CDER) Division of Pulmonary, Allergy and Rheumatology Products, has taken a job this month as senior vice president at AstraZeneca.

  • Amgen Seeks Clarity on Whether Biologics' Suffixes Could Cause Misbranding or Adulteration Issues

    • 27 March 2018
    Amgen is raising questions about whether the addition of suffixes to nonproprietary names of biologics and biosimilars could cause the products to be deemed by the US Food and Drug Administration (FDA) to be misbranded or adulterated because they do not adhere to the appropriate USP monographs.
     

  • Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    • 17 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.
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Recon
Recon: Bluebird's gene therapy eliminates blood transfusions for some beta-thalassemia patients
19 April 2018
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
Recon: Rigel wins first FDA approval; Abbott shares down as device sales grow Recon: Advent in Talks to Buy Sanofi Generics Business Recon: Merck and Bristol-Myers Offer Positive Lung Cancer Data
Regulatory News
Startups, Small Device Firms in ‘Wait-and-See Mode’ Over Health Canada MDSAP Requirements
19 April 2018
As Health Canada continues to tweak its Medical Device Single Audit Program (MDSAP) with the goal of transitioning ahead of its compliance deadline, several issues facing small- to medium-sized device companies remain unaddressed.
Johnson and McCaskill to FDA: Loperamide Decision Could Have Unintended Consequences FDA Finalizes ICH Q7 Questions and Answers on GMPs for APIs FDA’s Regulation of CDS Software: Will Physicians Have to Understand the Underlying Algorithms?
Feature Articles
Regulatory and Economic Challenges for Gene Therapy Utilization
17 April 2018

This article addresses pricing and reimbursement challenges associated with clinical utilization of approved gene therapies. The authors recommend potential approaches to resolve these challenges, the implementation of which may help solve issues related to the high cost of these therapies and encourage continued innovation and further development of advanced gene therapies.

Regulatory and Economic Challenges for Gene Therapy Utilization US and EU Veterinary Medical Device Regulation Public Availability of Expanded Access Policy: how to Comply With new Requirements
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
17 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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5 Reasons to Send Your Employees to RAPS Regulatory Convergence
11 April 2018
Professional development is important for both individuals and the organizations they work for. But conferences can be expensive and when you oversee multiple employees, keeping within your budget while choosing the most beneficial conference or training to send them to can be a challenge. For regulatory professionals and teams, RAPS’ Regulatory Convergence is a unique event with a lot to offer. Why should you send your employees to this premier regulatory conference? Here are five compelling reasons to consider.
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20 February 2018
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