• 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.
  • 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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