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    CDRH Draft Guidance Tackles Nitinol Devices

    • 18 April 2019
    As part of a broader effort to address potential safety issues from materials in medical devices, the US Food and Drug Administration (FDA) proposed technical considerations for nitinol-containing devices.
     
  • Regulatory NewsRegulatory News

    Australia and Canada Jointly Approve Breast Cancer Drug

    • 18 April 2019
    As part of a push toward regulatory convergence, Health Canada and Australia’s Therapeutic Goods Administration (TGA) last week jointly approved Eli Lilly’s Verzenio (abemaciclib) for the treatment of metastatic breast cancer.
     
  • Regulatory NewsRegulatory News

    CDRH Drafts Guidance on Quantitative Imaging

    • 18 April 2019
    Manufacturers looking for premarket submission recommendations for medical devices that generate quantitative imaging values have a new resource as the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released draft guidance Thursday.
     

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  • FDA Proposes Major Changes to Mammography Regulations

    • 27 March 2019
    The US Food and Drug Administration (FDA) on Wednesday proposed a new rule that would modernize mammography regulations and require mammography facilities to provide patients with more information on breast density.
     

  • FDA Drafts Guidance on Inspections of Medical Device Establishments

    • 28 March 2019
    The US Food and Drug Administration (FDA) issued draft guidance on Thursday to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments.
     

  • FDA to Launch New Website Next Week

    • 16 April 2019
    In his first “all hands” speech at the US Food and Drug Administration’s (FDA) White Oak campus on Tuesday, Acting Commissioner Ned Sharpless explained how he will pick up where Scott Gottlieb left off, and how next week, FDA will launch a new and improved FDA.gov website.

  • EU Device Coordination Group Offers Eudamed Guidance

    • 15 April 2019
    The EU’s Medical Device Coordination Group (MDCG) on Monday released two new documents explaining how legacy devices can be registered in Eudamed without a unique device identifier (UDI) and how device companies will have until November 2021 to register device data elements in Eudamed.
     
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Recon
Recon: Low Dose of Pfizer, Lilly Painkiller Misses Goals in Phase III Study
19 April 2019
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: Low Dose of Pfizer, Lilly Painkiller Misses Goals in Phase III Study Recon: Mustang Bio Soars After Gene Therapy Appears to Cure ‘Bubble Boy’ Patients Recon: Roche Raises Forecasts on Strong Sales of New Drugs; CVS Fined for Filling Fake Percocet Prescriptions
Regulatory News
FDA Approves First Generic Naloxone Nasal Spray for Opioid Overdose Treatment
19 April 2019
Teva Pharmaceuticals USA snagged US Food and Drug Administration (FDA) final approval for the first generic naloxone hydrochloride nasal spray known as Narcan, the agency announced on Friday.
 
FDA Approves First Generic Naloxone Nasal Spray for Opioid Overdose Treatment Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH DTC Drug Advertising: Study Finds Mixed Impact on Patients, Prescribers
Feature Articles
Similarity Approach for Complex Drugs: Biologics and Non-Biological Complex Drugs
15 April 2019
This article examines regulatory issues related to approvals of biosimilars and Non-Biological Complex Drugs (NBCDs) by both the European Medicines Agency and the US Food and Drug Administration with a focus on issues regarding similarity and bioequivalence
Similarity Approach for Complex Drugs: Biologics and Non-Biological Complex Drugs Chinese Health Policy and Regulatory Authorities Overview Minimal Residual Disease as a Surrogate Endpoint for Product Development for Multiple Myeloma: Comparing FDA and EMA Guidances
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
16 April 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.

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