• 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.
  • Regulatory NewsRegulatory News

    PIC/S Adopts New Guidelines on Shared Facilities, Revisions to GMP Guide

    • 21 June 2018
    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has adopted new guidelines on cross-contamination in shared facilities and implemented revisions to several of the sections in its good manufacturing practices (GMP) guide.
  • Regulatory NewsRegulatory News

    FDA Withdraws Guidance on Biosimilar Analytical Studies

    • 21 June 2018
    In response to industry concerns, the US Food and Drug Administration (FDA) on Thursday announced it has withdrawn its draft guidance on evaluating studies used to demonstrate analytical similarity between a biosimilar and reference biologic.
  • 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.
  • Regulatory NewsRegulatory News

    FDA Issues Guidance on Drugs to Treat Epidermolysis Bullosa

    • 18 June 2018
    The US Food and Drug Administration (FDA) on Friday released a draft guidance aimed at helping sponsors develop drugs to treat epidermolysis bullosa (EB), a group of genetic disorders that cause fragile skin and blistering.
  • Feature ArticlesFeature Articles

    Emerging Technology Integration in FDA’s Drug Approval Process

    • 18 June 2018

    This article discusses important aspects of the US Food and Drug Administration’s (FDA’s) “Emerging Technology Program” with a focus on emerging technology, such as continuous manufacturing and 3D printing, and details what information is to be included in drug submissions. The authors highlight a number of benefits of the program, including the synergy created between FDA and the pharmaceutical industry.

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