Top 5 Articles

Latest regulatory information from the EIPG Website
  1. Development of therapeutic protein biosimilars

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.”
  2. Draft ICH guideline E8 (R1) on general considerations for clinical studies

    The European Medicines Agency have published: Scientific guideline: ICH guideline E8 (R1) on general considerations for clinical studies – Step 2b, draft: consultation open.
  3. Considerations in demonstrating interchangeability with a reference product

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Considerations in Demonstrating Interchangeability With a Reference Product.”
  4. Determining whether to submit an ANDA or a 505(b)(2) application

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Determining Whether to Submit an ANDA or a 505(b)(2) Application.”
  5. Maximal usage trials for topically applied active ingredients in OTC monographs

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The -Counter Monograph: Study Elements and Considerations.”