Top 5 Articles

Latest regulatory information from the EIPG Website
  1. Developing drugs for treatment of cutaneous manifestations of epidermolysis bullosa

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations.”
  2. Nonclinical evaluation for anticancer pharmaceuticals

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals – Questions and Answers.”
  3. Evaluation of medicinal products indicated for treatment of bacterial infections

    The European Medicines Agency have published: Scientific guideline: Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, draft: consultation open.
  4. Developing systemic drug products for pre-exposure prophylaxis of HIV-1 infection

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.”
  5. Limited population pathway for antibacterial and antifungal drugs

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.”