Top 5 Articles

Latest regulatory information from the EIPG Website
  1. Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers.”
  2. Metered Dose Inhaler and Dry Powder Inhaler drug products

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products—Quality Considerations.”
  3. Special protocol assessment

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Special Protocol Assessment.”
  4. Clinical investigation of medicinal products in the pediatric population

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population.”
  5. Scientific and ethical considerations for inclusion of pregnant women in clinical trials

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.”