• Regulatory NewsRegulatory News

    FDA Offers Technical Specifications for Submitting NGS Data on Antivirals

    • 18 July 2019
    The US Food and Drug Administration (FDA) on Thursday published a technical specifications document to help sponsors submit next generation nucleotide sequence analysis procedures and data in support of resistance assessments for the development of antiviral drugs.
  • Regulatory NewsRegulatory News

    FDA to Study Physicians’ Interpretations of Drug Information

    • 18 July 2019
    The US Food and Drug Administration (FDA) on Thursday said its Office of Prescription Drug Promotion (OPDP) will conduct a study to determine how factors such as information source, graphical presentations and time can influence physicians’ interpretation of information about prescription drugs presented in scientific journals versus promotional materials.
  • Regulatory NewsRegulatory News

    Patient Registries May Prove Valuable in Regulatory Decisions, EMA Study Finds

    • 18 July 2019
    Although patient registries can be heterogenous in their quality and design, a new study in Drug Safety co-authored by a European Medicines Agency (EMA) official explains how patient registries could provide valuable data for regulatory decisions.
  • Regulatory NewsRegulatory News

    Office of Generic Drugs Explains Research Conducted in First Year of GDUFA II

    • 18 July 2019
    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Thursday released a report on the two dozen research grants awarded related to complex generics in 2018, as well as the research done in seven other areas, including data analytics and combination products. 

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  • US and EU Fully Implement Mutual Agreement on GMP Inspections

    • 12 July 2019
    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on Friday said they have now fully implemented a plan that will allow member state regulators and FDA to mutually rely on each other’s good manufacturing practice (GMP) inspections of drug facilities.
  • EC Offers Two New Guidance Documents on MDR/IVDR

    • 01 July 2019
    The European Commission (EC) on Monday released one new guidance on persons responsible for regulatory compliance under the Medical Device Regulation (MDR) and the in vitro Diagnostic Device Regulation (IVDR), and another guidance on the implant card required by MDR.
  • Manufacturing Concerns Lead FDA to Pull 31 Apotex ANDAs

    • 09 July 2019
    The US Food and Drug Administration (FDA) on Tuesday said it is withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex after manufacturing deficiencies were found at two of the company’s plants.
  • UL UK to Sunset Operations Under EU’s Medical Device Directive

    • 08 July 2019
    UL UK says it will no longer operate as a notified body (NB) under the EU’s medical device directive (MDD) and limit its work under the in vitro diagnostic directive (IVDD).
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