Top 5 Articles

Latest regulatory information from the EIPG Website
  1. Draft ICH guideline M10 on bioanalytical method validation

    The European Medicines Agency have published: Scientific guideline: Draft ICH guideline M10 on bioanalytical method validation – Step 2b, draft: consultation open.
  2. Nonclinical development of pharmaceuticals for severely debilitating or life-threatening hematologic disorders

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.”
  3. Enrichment strategies for clinical trials to support determination of effectiveness

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products.”
  4. Risk-based approach to monitoring of clinical investigations

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.”
  5. Minimum age for pediatric patients in cancer clinical trials

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients.”