Top 5 Articles

Latest regulatory information from the EIPG Website
  1. Handling and shipping of IMPs for human use in accordance with GCP and GMP

    The European Medicines Agency have published: Scientific guideline: Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consultation open.
  2. Maximal usage trials for topical active ingredients being considered for inclusion in an Over-the-Counter monograph

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.”
  3. Developing drugs for prophylaxis of inhalational anthrax

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.”
  4. OTC sunscreen drug products marketed without an approved application

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Enforcement Policy — OTC Sunscreen Drug Products Marketed Without an Approved Application.”
  5. Bioanalytical method validation

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Bioanalytical Method Validation.”