Top 5 Articles

Latest regulatory information from the EIPG Website
  1. Core summary for product characteristics for human albumin solution

    The European Medicines Agency have published: Scientific guideline: Guideline on core summary for product characteristics for human albumin solution – Revision 3, adopted.
  2. Clinical investigation of recombinant and human plasma-derived factor VIII products

    The European Medicines Agency have published: Scientific guideline: Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products – Revision 2, adopted.
  3. Core SmPC for human plasma derived and recombinant coagulation factor VIII products

    The European Medicines Agency have published: Scientific guideline: Guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products – Revision 3, adopted.
  4. Use of expansion cohorts in clinical trials for oncology drugs and biologics

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.”
  5. Dissolution testing for immediate-release solid oral dosage forms with high solubility drug substances

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances.”