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    Connecticut AG Releases Unredacted Generic Drug Price Fixing Complaint

    • 24 June 2019
    Following a court motion to unseal the unredacted complaint against 20 generic drugmakers, including Teva Pharmaceuticals, Novartis’ Sandoz and Mylan Pharmaceuticals, Connecticut Attorney General William Tong on Monday released the more than 500-page document.
  • Regulatory NewsRegulatory News

    Drugmakers Call for Changes to FDA Bioavailability Guidance

    • 24 June 2019
    Drugmakers and industry groups are calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on bioavailability (BA) studies submitted as part of an investigational new drug (IND) application or new drug application (NDA).
  • Regulatory NewsRegulatory News

    Australia Preps for Medicine Ingredient Name Changes

    • 24 June 2019
    As part of a push to align the names of Australia’s medicinal ingredients with names used internationally, Australia’s Therapeutics Goods Administration (TGA) has been transitioning more than 220 ingredient names as part of a process that will last until 1 May 2020.

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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).
     

  • Another Notified Body Bows Out Ahead of EU MDR: 'Investment Too High’

    • 18 June 2019
    Swiss notified body (NB) QS ZÜRICH AG has decided that it will not pursue designation under the new EU medical devices regulation (MDR), although EN ISO 13485 support will remain.
     

  • 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: BMS to Divest Celgene Psoriasis Drug Otezla to Appease FTC in Merger
24 June 2019
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: BMS to Divest Celgene Psoriasis Drug Otezla to Appease FTC in Merger Recon: FDA Rejects Daiichi Sankyo Blood Cancer Drug After Japanese Approval Recon: Sanofi to Lay Off 466 in France and Germany in Shift to Cancer, Gene Therapies
Regulatory News
FDA Updates List of Off-Patent, Off-Exclusivity Drugs Without Generic Competition
24 June 2019
Since 2017, the US Food and Drug Administration (FDA) has been striving to help generic companies understand which brand name drug products are no longer protected by patents or exclusivities and currently have no generic competitors.
FDA Updates List of Off-Patent, Off-Exclusivity Drugs Without Generic Competition IVDs Top the List of Devices Seeing Field Safety Corrective Actions, Report Shows Connecticut AG Releases Unredacted Generic Drug Price Fixing Complaint
Feature Articles
Modernizing Canada’s Medical Nutrition Regulations for Food
24 June 2019
This article addresses the Canadian government’s opportunity to modernize its medical nutrition regulations for food and presents key learnings from the structure and implementation of several regulatory frameworks for Food for Special Medical Purposes (FSMP) globally.
Modernizing Canada’s Medical Nutrition Regulations for Food Dietary Supplements and Public Safety: A Defense of DSHEA’s “Three-Legged Stool” Regulatory Challenges in Medical Foods: Natural Variations in Ingredients of Agricultural Origin
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
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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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