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    Additive/3D Printing Manufacturing: Regulatory Concerns

    • 20 June 2018

    This article discusses “3D printing” or “additive manufacturing” for the manufacturing of medical devices, including replacement body parts. It draws much of its material from a new US FDA Guidance document that discusses the unique issues posed by this technology, key concerns due to radically different features of such manufacturing and various ways to address the resulting FDA quality and regulatory concerns relative to ultimate patient safety.

  • Regulatory NewsRegulatory News

    EU Pharmacovigilance Fees Rise 1.7 Percent

    • 12 July 2018
    The European Commission on Wednesday raised the fees pharmaceutical companies pay related to pharmacovigilance activities in the EU by 1.7% to keep pace with inflation in 2017.
  • Regulatory NewsRegulatory News

    FDA to Form New Drug Shortages Task Force

    • 12 July 2018
    As the number of new drug shortages has steadily declined since 2011, the US Food and Drug Administration (FDA) on Thursday announced the creation of a new drug shortages task force, led by Keagan Lenihan, the FDA’s associate commissioner for strategic initiatives, and including leaders from the Centers for Medicare and Medicaid Services (CMS) and the Department of Veterans Affairs. 
     
  • Regulatory NewsRegulatory News

    Recon: Novartis joins exodus out of antibiotics

    • 12 July 2018
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
     
  • Feature ArticlesFeature Articles

    Digesting FDA’s New Regulatory Definition of Dietary Fiber and its Impact on the US Food and Dietary Supplement Industry

    • 12 July 2018

    This article outlines the new regulatory definition of dietary fiber under the US Food and Drug Administration’s final rule for Nutrition and Supplement Facts labeling, including requirements for declaring ingredients as dietary fiber on the label outlined in the regulation.

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  • FDA Warns Chinese API Manufacturer for GMP Violations

    • 27 June 2018

    The US Food and Drug Administration (FDA) has warned Chinese active pharmaceutical ingredient (API) manufacturer Henan Lihua Pharmaceutical Co. Ltd. for good manufacturing practice (GMP) violations stemming from an inspection last December.

  • EU Recalls Some Valsartan Medicines Over Impurity

    • 06 July 2018
    EU authorities have initiated a recall of certain valsartan-containing medicines with active substance supplied by China-based Zhejiang Huahai Pharmaceuticals, pending a European Medicines Agency (EMA) review of an impurity detected.
     

  • FDA Unveils 6 New Draft Guidances on Gene Therapy

    • 11 July 2018
    As first announced in January, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Wednesday offered a swath of new draft guidance documents on human gene therapies – offering a look at what it expects from an industry that’s beginning to take off.
     

  • FDA to Release List of Surrogate Endpoints in Oncology

    • 25 June 2018
    Scott Gottlieb, FDA Commissioner, said Monday at the National Press Club in Washington, DC that his agency will release a list of surrogate endpoints used in cancer drug development soon.
     
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Recon
Recon: FDA Panel Backs Malaria Drug; Senate Report on Trump Lawyer and Novartis
13 July 2018
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
Recon: Pfizer Agrees to Postpone Drug Price Hikes, Plans Split Into 3 Units Recon: Trump Shames Pharma Over Price Hikes, FTC Clears $62B Takeda-Shire Deal Recon: CMS Quietly Quit Deal to Pay for Kymriah Performance
Regulatory News
Health Canada Clarifies Policies for Notifications of Foreign Regulatory Actions
13 July 2018
 Health Canada issued new guidance on Thursday to aid pharmaceutical companies in complying with previously set requirements on notifications of foreign regulatory actions.
 
Pfizer’s Hospira Site in India Lands Another FDA Form 483 FDA Releases Draft ICH Guidance Revision on Elemental Impurities Hypertension Drug Development: FDA Draft Guidance Outlines Recommendations
Feature Articles
Digesting FDA’s New Regulatory Definition of Dietary Fiber and its Impact on the US Food and Dietary Supplement Industry
12 July 2018

This article outlines the new regulatory definition of dietary fiber under the US Food and Drug Administration’s final rule for Nutrition and Supplement Facts labeling, including requirements for declaring ingredients as dietary fiber on the label outlined in the regulation.

Digesting FDA’s New Regulatory Definition of Dietary Fiber and its Impact on the US Food and Dietary Supplement Industry Food Supplements in the European Union: the Difficult Route to Harmonization Four Gone, but not Forgotten
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
30 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.

RAPS' Latest
Focus on: Cary Coglianese (Part 2 of 2)
12 July 2018

Part two of a two-part interview with Cary Coglianese, director of the Penn Program on Regulation at the University of Pennsylvania Law School. He shares his thoughts on regulatory harmonization, trends to watch and his own personal values, among other topics.

Focus on: Cary Coglianese (Part 1 of 2) Focus on: Daniela Drago Knowing Regulations Not Enough, Says Expert who Will Help Guide RAPS Exec Program Participants
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