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  • Regulatory NewsRegulatory News

    EMA-FDA: Agencies Want to Strengthen Collaboration

    • 22 June 2018

    The European Medicines Agency (EMA) on Friday gave an update on the current and future status of its ongoing collaboration with the US Food and Drug Administration (FDA).

  • ReconRecon

    Recon: White House Proposes Taking the Food out of FDA

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

    Australia Relaxes Oversight on Some Low Risk Drugs, Devices

    • 21 June 2018
    The Australian government has endorsed several regulatory activities aimed at reducing the Therapeutic Goods Administration’s (TGA) oversight on a range of low risk pharmaceuticals and medical devices.
     
  • Regulatory NewsRegulatory News

    Public Citizen Calls on FDA to Withdraw Takeda Gout Drug

    • 21 June 2018
    Nonprofit advocacy group Public Citizen is calling on the US Food and Drug Administration (FDA) to pull Takeda Pharmaceuticals' gout drug Uloric (febuxostat) from the market after a postmarketing study of the drug found higher rates of fatal cardiovascular events and all-cause mortality in patients taking the drug.
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    Feature ArticlesFeature Articles

    Additive/3D Printing Manufacturing: Regulatory Concerns

    • 20 June 2018

    This article discusses “3D printing” or “additive manufacturing” for the manufacturing of medical devices, including replacement body parts. It draws much of its material from a new US FDA Guidance document that discusses the unique issues posed by this technology, key concerns due to radically different features of such manufacturing and various ways to address the resulting FDA quality and regulatory concerns relative to ultimate patient safety.

  • Feature ArticlesFeature Articles

    FDA Releases Novel Technical Framework for 3D Printed Medical Devices

    • 19 June 2018

    This article discusses the value, potential and challenges of using 3D printing (Additive Manufacturing (AM)) to develop products for use in the pharmaceutical industry. The author reviews the US Food and Drug Administration’s (FDA’s) guidance on AM in terms of design as well as manufacturing and device testing considerations. Emphasis is placed on the evolutionary aspects of providing final guidance on 3D printed products as well as the need for manufacturers using AM to establish early and frequent engagement with FDA through the AM product development process.

  • Regulatory NewsRegulatory News

    Pre-Cert Pilot: FDA Updates on Framework, Asks for Input

    • 19 June 2018
    The US Food and Drug Administration (FDA) provided new information about its software pre-certification pilot Tuesday with the release of an updated version of its working model.
  • Regulatory NewsRegulatory News

    EMA Updates its Brexit Guidance for Industry

    • 19 June 2018
    The European Medicines Agency (EMA) on Tuesday updated two guidance documents intended to assist drugmakers in their Brexit preparations.
  • ReconRecon

    Recon: Roche Buys the Rest of Foundation Medicine for $2.4B

    • 19 June 2018
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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Recon
Recon: White House Proposes Taking the Food out of FDA
22 June 2018
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: Rising Insulin Prices Spark Outrage; Six Biotechs Raise $568M in IPOs Recon: Amgen's Blincyto Gets Full EU Approval for Rare Leukemia; GSK, Gilead Headed for HIV Showdown Recon: Roche Buys the Rest of Foundation Medicine for $2.4B
Regulatory News
Continuous Glucose Monitors: FDA Grants Pediatric Indication to Medtronic Device, Approves Senseonics System
22 June 2018
Both of these CGM systems are designed to measure glucose levels in patients’ body every five minutes using sensors surgically implanted under the skin. 
CBER Launches new Program for Early Interaction With Biologics Developers EMA-FDA: Agencies Want to Strengthen Collaboration Australia Relaxes Oversight on Some Low Risk Drugs, Devices
Feature Articles
Additive/3D Printing Manufacturing: Regulatory Concerns
20 June 2018

This article discusses “3D printing” or “additive manufacturing” for the manufacturing of medical devices, including replacement body parts. It draws much of its material from a new US FDA Guidance document that discusses the unique issues posed by this technology, key concerns due to radically different features of such manufacturing and various ways to address the resulting FDA quality and regulatory concerns relative to ultimate patient safety.

FDA Releases Novel Technical Framework for 3D Printed Medical Devices Emerging Technology Integration in FDA’s Drug Approval Process Regulatory Challenges for Artificial Intelligence Applications in Healthcare
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
30 April 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: Daniela Drago
17 May 2018
A conversation with Daniela Drago, head of the regulatory affairs program at The George Washington University and chair of the RAPS DC/Baltimore Chapter, as part of our new Regulatory Focus interview series, ‘Focus on…,’ where we talk with regulatory leaders, thinkers and influencers from a variety of backgrounds.
Knowing Regulations Not Enough, Says Expert who Will Help Guide RAPS Exec Program Participants 8 Networking Tips for Regulatory Convergence Attendees RAPS, CAPRA Collaborate to Bring Canadian Regulators and Expertise to Global Audience
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