• 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.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe

Most Viewed Articles

Regulatory Focus ArticlesRSS 2.0