Covering a multitude of subjects, the Agency published eight new guidance documents ranging from the ICH M9 BCS classification system to a Q&A document on qualified infectious disease designations.
Here is a list of the eight guidance documents.
- M9 Biopharmaceutics Classification System-Based Biowaivers (here)
- E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials (here)
- Q3D(R2) – Guideline for Elemental Impurities (here)
- S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals (here)
- Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry (here)
- Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex (here)
- S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals (here)
- Qualified Infectious Disease Product Designation Questions and Answers (here)
Three are revised versions of previously issued guidances, but all are ICH-based, with a “mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed, registered, and maintained in the most resource-efficient manner”.
Clinical, safety, quality, regulatory, and procedural issues covering new drugs, generics drugs and biologics are discussed in detail. The guidances and a brief description of each can be found here, but you better hurry, as this is listed in the What’s New Section of the FDA web page under May 11 and will be gone in about seven days Happy reading! And look for some surprises and, if you can figure out how the FDA will address some of them – please let me know. Because they are ICH-based, it is likely that regional authorities will still maintain their existing specific requirements when differences are permitted.