Top 5 Articles

Latest regulatory information from the EIPG Website
  1. Voluntary consensus standards related to pharmaceutical quality

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.”
  2. Clinical investigation of medicinal products for the treatment of gout

    The European Medicines Agency have published: Scientific guideline: Guideline on clinical investigation of medicinal products for the treatment of gout, draft: consultation open.
  3. Developing drugs for treatment of eosinophilic esophagitis

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Eosinophilic Esophagitis: Developing Drugs for Treatment.”
  4. Principles of premarket pathways for combination products

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Principles of Premarket Pathways for Combination Products.”
  5. Public warning and notification of recalls

    The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry and FDA staff entitled “Public Warning and Notification of Recalls.”