If your email program has trouble displaying this email, view as a webpage. Recently Posted Guidance Documents 5/11/2021 - M9 Biopharmaceutics Classification System-Based Biowaivers 5/11/2021 - Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex 5/11/2021 - E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials: Guidance for Industry 5/11/2021 - Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry: Guidance for Industry 5/11/2021 - S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals : Guidance for Industry 5/11/2021 - Qualified Infectious Disease Product Designation Questions and Answers: Guidance for Industy 5/11/2021 - S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals : International Council for Harmonisation; Draft Guidance for Industry 5/11/2021 - Q3D(R2) – Guideline for Elemental Impurities: Draft International Council for Harmonisation; Draft Guidance for Industry Guidance Document Search Search all FDA official guidance documents and other regulatory guidance

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