Top 5 Articles

Latest regulatory information from the EIPG Website
  1. Submitting next generation sequencing data

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications Document.”
  2. Providing regulatory submissions in electronic format

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Revision 7).”
  3. Developing gonadotropin-releasing hormone analogues for advanced prostate cancer

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues.”
  4. European Commission Safety Features Q&A document updated

    The European Commission has published an updated version, Version 15, of the Questions and Answers document on the Safety Features for Medicinal Products for Human Use.
  5. Hormonal drug products intended to prevent pregnancy

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy.”