Top 5 Articles

Latest regulatory information from the EIPG Website
  1. Implementing ‘safety features’ under the Falsified Medicines Directive

    The Medicines and Healthcare products Regulatory Agency (MHRA) has published: Open consultation: Implementing ‘safety features’ under the Falsified Medicines Directive.
  2. Conducting studies of drugs to treat patients on a background of multiple antihypertensive drugs

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs.”
  3. Elemental impurities

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Q3D(R1) Elemental Impurities.”
  4. Human gene therapy for retinal disorders

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry.”
  5. Long term follow-up after administration of human gene therapy products

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry.”