Top 5 Articles

Latest regulatory information from the EIPG Website
  1. Member States Supervision of the NMVSs/NMVOs

    The European Commission has published the Inspection report template for National Competent Authorities as part of the Member States Supervision of the National Medicines Verification Systems/National Medicines Verification Organisations.
  2. Nonclinical safety testing in support of development of paediatric medicines

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines.”
  3. Labeling for human prescription drug and biological products approved under the Accelerated Approval Regulatory Pathway

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.”
  4. Drug development for rare diseases

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Rare Diseases: Common Issues in Drug Development.”
  5. Amendments and requests for final approval to tentatively approved ANDAs

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs.”