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    May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says

    • 14 June 2019
    While acknowledging that the May 2020 deadline for the implementation of the new medical devices regulation (MDR) is a “significant challenge,” the European Commissioner for Health and Food Safety said Friday that the industry and government “are on course to meet it.”
     
  • Regulatory NewsRegulatory News

    FDA and BioCelerate Join Forces on Nonclinical Research

    • 13 June 2019
    The US Food and Drug Administration (FDA), under a new collaboration, is poised to explore how to provide better support for early-stage research and development.
     
  • Regulatory NewsRegulatory News

    FDA Warns of One Death Linked to Fecal Transplants

    • 13 June 2019
    The US Food and Drug Administration (FDA) on Thursday warned medical and scientific communities and other interested persons of the potential risk of transmitting multi-drug resistant organisms (MDROs) via poop transplants, otherwise known as fecal microbiota for transplantation (FMT).
     
  • Regulatory NewsRegulatory News

    Merck, IBM, KPMG and Walmart Selected for FDA Blockchain Pilot

    • 13 June 2019
    The US Food and Drug Administration (FDA) has selected Merck, IBM, KPMG and Walmart to participate in a pilot evaluating blockchain technology to enhance supply chain security, according to a joint press release from the companies.

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  • UK NB Will Not Apply for EU MDR/IVDR

    • 12 June 2019
    London-based Lloyd's Register Quality Assurance (LRQA) announced Wednesday that it will withdraw from its notified body (NB) services under the EU’s current medical device and in vitro diagnostic directives and will not apply to be an NB under the new medical device and in vitro diagnostic regulations (MDR/IVDR).
     

  • TÜV SÜD Becomes Second NB to be Designated Under EU MDR

    • 22 May 2019
    Germany-based TÜV SÜD Product Service GmbH Zertifizierstellen on Wednesday became the second notified body (NB) to be designated and notified under the new EU Medical Devices Regulation (MDR).
     

  • FDA to Explore Randomized Trials Using RWE for Regulatory Purposes

    • 07 June 2019
    The US Food and Drug Administration (FDA) said Friday it will host a 2-day public workshop on leveraging randomized clinical trials to generate real-world evidence (RWE) for regulatory decisions.
     

  • FDA Approves First NDA Under Real-Time Oncology Review Pilot

    • 28 May 2019
    As the US grapples with whether Novartis’ new gene therapy for spinal muscular atrophy should cost $2.1 million, the US Food and Drug Administration (FDA) on Friday also quietly signaled that another Novartis drug would effectively kick off a new way for cancer drugs to be approved more quickly.
     
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Recon
Recon: Bluebird Prices Gene Therapy Zynteglo at €1.575M Over 5 Years
14 June 2019
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: Bluebird Prices Gene Therapy Zynteglo at €1.575M Over 5 Years Recon: GSK Teams up With CRISPR Pioneers for New Drug Discovery Lab Recon: France’s Dassault to Buy Medidata for $5.8B
Regulatory News
Drugmakers Sue HHS for Trying to Add Prices to DTC Ads
14 June 2019
Amgen, Merck, Eli Lilly and the Association of National Advertisers on Friday sued the Department of Health and Human Services (HHS) because of a rulemaking that would require pharmaceutical list prices to be shown in direct-to-consumer (DTC) drug advertisements on television.
 
Drugmakers Sue HHS for Trying to Add Prices to DTC Ads ICH Adds Four New Regulatory Observers May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says
Feature Articles
Severe Acute Malnutrition (SAM): The Value of a Ready to use Therapeutic Food (RUTF) Guideline
14 June 2019
This article discusses the value of a Ready-to-use Therapeutic Food (RUTF) and the guidelines for its use.
Severe Acute Malnutrition (SAM): The Value of a Ready to use Therapeutic Food (RUTF) Guideline Update on the Regulatory Status of Cannabidiol in Food and Dietary Supplements and Future Prospects The Value of Engagement With Trade Associations in Policymaking, Regulation and Standardization
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
24 May 2019
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 FDA’s Priority Review Vouchers Regulatory Explainer: Everything You Need to Know About Biosimilars Regulatory Explainer: FDA User Fee Reauthorizations From 2018 to 2022
About Regulatory Focus

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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: Allison Komiyama
31 May 2019
Read our interview with Allison Komiyama, an expert in regulatory submissions, quality systems and biocompatibility evaluation, who heads her own regulatory consulting firm, AcKnowledge Regulatory Strategies. This is the latest in the 'Focus on...' series in Regulatory Focus, featuring interviews with a variety of regulatory leaders, thinkers and influencers.
Focus on: Allison Komiyama MDR, IVDR and ‘Navigating the Grey’ Key Topics at RAPS Regulatory Conference Europe Opening Focus on: Bill Sietsema
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