• Feature ArticlesFeature Articles

    Performing a GMP Audit

    • 06 December 2018
    This article discusses the first-time experience of performing an audit from a regulatory professional’s perspective and is directed toward those who may never have participated in an audit.
  • Regulatory NewsRegulatory News

    FDA Leadership Calls for LDT Reforms

    • 06 December 2018
    While championing advances made in diagnostic technology in recent years, top officials from the US Food and Drug Administration (FDA) are calling for a new regulatory framework for in vitro clinical tests (IVCTs) and laboratory developed tests (LDTs).
  • Regulatory NewsRegulatory News

    FDA Flags Lack of Design Controls at Mibo Medical Group

    • 06 December 2018
    A May inspection at a Mibo Medical Group manufacturing site in Texas revealed a lack of established procedures for controlling the design of its class II dry eye treatment device, distributed since 2014.
  • ReconRecon

    Recon: HHS Defends Drug Pricing Proposal; Mallinckrodt to Spin Off Specialty Generics Business

    • 06 December 2018
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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