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  • Regulatory NewsRegulatory News

    AdvaMed Raises Concerns Over FDA’s Medical Device Safety Action Plan

    • 17 August 2018
     In a comment submitted on the US Food and Drug Administration’s (FDA) recent action plan to promote medical device safety, the Advanced Medical Technology Association (AdvaMed) raised several concerns with the merit and logistics of the proposal.
     
  • Regulatory NewsRegulatory News

    Microbiome-Based Products: FDA Delves Into the Unregulated

    • 17 August 2018
    As part of a broader push to advance the regulatory science around microbiome-based products, the US Food and Drug Administration and National Institutes of Health will host a workshop on 17 September.
     
  • Regulatory NewsRegulatory News

    FDA and NCI Draft Pediatric Molecular Target List

    • 17 August 2018
    Thanks to the law reauthorizing the user fee programs, known as the FDA Reauthorization Act (FDARA), FDA’s Oncology Center of Excellence Pediatric Oncology Program recently drafted a list of molecular targets to provide better guidance to industry in planning for initial pediatric study plan submissions.
     
  • ReconRecon

    Recon: Novo Nordisk Acquires Diabetes Firm Ziylo for $800M

    • 17 August 2018
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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    Drug Delivery Combinations and new EU Medical Device Regulations

    • 17 August 2018

    This article discusses regulatory issues related to Drug Device Combinations (DDCs) and speculates on how they will continue to be regulated as medicines under the new EU Medical Device Regulations. 

  • Regulatory NewsRegulatory News

    Device Accessories: FDA Drafts List for Reclassification to Class I

    • 17 August 2018
    The US Food and Drug Administration (FDA) on Thursday published a proposed list of medical device accessories that it believes can be reclassified to the agency's lowest risk class, Class I.
  • Regulatory NewsRegulatory News

    FDA Extends Malfunction Summary Reporting Program to Combo Products

    • 16 August 2018
    In a Thursday notice finalizing a new industry program for reporting device malfunctions, the US Food and Drug Administration (FDA) announced it has extended the eligibility of manufacturers that can chose to participate to include those with combination products.
     
  • Regulatory NewsRegulatory News

    FDA Approves First Generic Versions of EpiPen

    • 16 August 2018
    The US Food and Drug Administration on Thursday approved Teva Pharmaceuticals’ first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis) in adults and children weighing more than 33 pounds.
     

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  • Dissolution Testing and Acceptance Criteria: FDA Finalizes Guidance

    • 08 August 2018
    The US Food and Drug Administration (FDA) on Wednesday released final guidance for sponsors on when a standard release test and criteria may be used in lieu of extensive method development and acceptance criteria-setting exercises.
     

  • EMA Updates on Recalled Valsartan Medicines

    • 02 August 2018
    An initial health risk assessment conducted by the European Medicines Agency (EMA) projects a hypothetical increase in cancer cases among patients who took certain medicines with a Chinese company’s active substance that was previously found to contain an impurity.
     

  • Brexit Guidance: MHRA Outlines What to Expect

    • 06 August 2018
    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Monday explained what life science companies can expect during the period that the Brexit agreement is implemented.
     

  • FDA Adds Context to Valsartan Recalls

    • 27 July 2018
    The US Food and Drug Administration (FDA) on 13 July announced a recall of certain batches of valsartan tablets because of an impurity, a chemical known as N-nitrosodimethylamine (NDMA). The amounts of NDMA found in the recalled batches of valsartan exceeded acceptable levels.
     
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Recon
Recon: Novo Nordisk Acquires Diabetes Firm Ziylo for $800M
17 August 2018
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: Pfizer Bets $425M on BioNTech to Develop Flu Vaccine; FDA Expands Kalydeco for Infant Use Recon: CNDA Says Chinese Vaccine Maker Sold 250,000 Substandard Baby Vaccines Recon: Biogen’s Spinraza Too Costly for Britain; China Invalidates Patent on Gilead Hepatitis C Drug
Regulatory News
AdvaMed Raises Concerns Over FDA’s Medical Device Safety Action Plan
17 August 2018
 In a comment submitted on the US Food and Drug Administration’s (FDA) recent action plan to promote medical device safety, the Advanced Medical Technology Association (AdvaMed) raised several concerns with the merit and logistics of the proposal.
 
Microbiome-Based Products: FDA Delves Into the Unregulated FDA and NCI Draft Pediatric Molecular Target List Device Accessories: FDA Drafts List for Reclassification to Class I
Feature Articles
Drug Delivery Combinations and new EU Medical Device Regulations
17 August 2018

This article discusses regulatory issues related to Drug Device Combinations (DDCs) and speculates on how they will continue to be regulated as medicines under the new EU Medical Device Regulations. 

An Update on Orphan Drugs in Canada Salt: Needed, Widely Used, Often Misunderstood Overcoming the Challenges in Getting Cancer Vaccines to Market
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
01 August 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
Risk Management: What Regulatory Professionals Need to Know
09 August 2018

Risk management experts, William Sietsema, PhD; and J. Michael Sprafka, MS, MPH, PhD, co-editors of RAPS’ second edition of Risk Management Principles for Devices and Pharmaceuticals answer questions about risk management, the latest developments and the new book.

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