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  • Regulatory NewsRegulatory News

    FDA Cites Korean Manufacturer Over Unapproved Device

    • 20 July 2018
    In a recent untitled letter to South Korea-based Ycellbio Medical, the US Food and Drug Administration (FDA) warned of potential violations against medical device regulations
  • Regulatory NewsRegulatory News

    IPRP Details Expectations for Biodistribution Assessments for Gene Therapies

    • 20 July 2018

    The newly formed International Pharmaceutical Regulators Programme (IPRP) has released a reflection paper laying out expectations for non-clinical biodistribution (BD) assessments for gene therapies (GT).

  • Regulatory NewsRegulatory News

    FDA Credits Pilots for Three-Week Review of New Kisqali Indication

    • 20 July 2018

    The US Food and Drug Administration (FDA) on Wednesday approved a new indication for Novartis' targeted breast cancer drug Kisqali (ribociclib) after reviewing the drug under two new pilot programs aimed at improving the efficiency of oncology drug submissions and evaluations.

  • Feature ArticlesFeature Articles

    Regulatory Requirements for Meal Replacement Products: An International Review

    • 20 July 2018

    This article reviews and discusses the regulatory status of meal replacement products internationally with an emphasis on 1991 Codex Alimentarius Commission (CODEX), relevant product categories, intended purposes and consumer confidence. Restructuring some of the regulations in the US may be useful to both manufacturers and consumers.

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    Feature ArticlesFeature Articles

    Revising the EU FSMP Regulatory Framework: Laying a Foundation for Future Nutritional Patient Care

    • 16 July 2018

    This article addresses the 2010-2017 full revision of the regulatory framework in the European Union (EU) for Food for Special Medical Purposes (FSMP) and summarizes key advocacy messages critical to the pragmatic and successful regulation of this special category of foods to ensure their availability to patients and healthcare professionals.

  • Feature ArticlesFeature Articles

    Regulatory Requirements for Meal Replacement Products: An International Review

    • 20 July 2018

    This article reviews and discusses the regulatory status of meal replacement products internationally with an emphasis on 1991 Codex Alimentarius Commission (CODEX), relevant product categories, intended purposes and consumer confidence. Restructuring some of the regulations in the US may be useful to both manufacturers and consumers.

  • Regulatory NewsRegulatory News

    Form 483 for Akorn’s Illinois Site Rekindles Questions on Fresenius Buyout

    • 20 July 2018
    Back in late February, Fresenius and Akorn traded barbs over whether Akorn breached US Food and Drug Administration (FDA) data integrity requirements that threatened the German drugmaker's $4.3 billion purchase of the US generics maker.
     
  • Regulatory NewsRegulatory News

    FDA Drafts 26 New Product Specific Guidances for Generic Drugmakers

    • 20 July 2018
    The batch of new and revised US Food and Drug Administration (FDA) guidance features 43 product-specific guidances, including 26 new guidances and 17 revised guidances that, when finalized, will describe FDA’s expectations on how to develop generic drugs that are therapeutically equivalent to their respective reference-listed drugs.
     
  • ReconRecon

    Recon: Sales of Essure birth control implant halted by Bayer

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

    FDA to Develop Importation Policy for Sole-Source Drugs

    • 19 July 2018
    At the direction of Department Health and Human Services (HHS) Secretary Alex Azar, the US Food and Drug Administration (FDA) on Thursday announced it will work to develop a policy to facilitate the importation of certain sole-source drugs in response to dramatic price hikes and supply disruptions.
  • Regulatory NewsRegulatory News

    Interchangeable Biosimilars: The Central Path to Lower Biologic Prices?

    • 19 July 2018
    With the first interchangeable biosimilars expected to come to market before 2020, anticipation has heightened on what kind of impact these products will have on the biologics market, particularly when competing with other non-interchangeable products.
     
  • Regulatory NewsRegulatory News

    Field Alert Report Submissions: FDA Offers Draft Q&A

    • 19 July 2018
    The US Food and Drug Administration (FDA) on Wednesday issued draft guidance providing the agency’s current thinking on the requirements for submitting field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs).
     

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  • 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.
     

  • 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 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.

  • 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.
     
Regulatory Focus ArticlesRSS 2.0
Recon
Recon: Sales of Essure birth control implant halted by Bayer
20 July 2018
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
Recon: Trump Plan to Lower Drug Prices Moves Forward on Several Fronts Recon: Following Pfizer, Novartis Hits Pause on Price Hikes Recon: Mylan Signs Licensing Deal on Humira with AbbVie
Regulatory News
FDA Cites Korean Manufacturer Over Unapproved Device
20 July 2018
In a recent untitled letter to South Korea-based Ycellbio Medical, the US Food and Drug Administration (FDA) warned of potential violations against medical device regulations
IPRP Details Expectations for Biodistribution Assessments for Gene Therapies FDA Credits Pilots for Three-Week Review of New Kisqali Indication Form 483 for Akorn’s Illinois Site Rekindles Questions on Fresenius Buyout
Feature Articles
Regulatory Requirements for Meal Replacement Products: An International Review
20 July 2018

This article reviews and discusses the regulatory status of meal replacement products internationally with an emphasis on 1991 Codex Alimentarius Commission (CODEX), relevant product categories, intended purposes and consumer confidence. Restructuring some of the regulations in the US may be useful to both manufacturers and consumers.

Opportunities and Challenges in New Nutritional Products Innovation Impact of Changing Scientific Recommendations on Nutrition Policies Revising the EU FSMP Regulatory Framework: Laying a Foundation for Future Nutritional Patient Care
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
19 July 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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