FDA Issues Six Draft Guidance Documents

On August 6, the FDA released a guidance entitled Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States. This guidance enforces the ICH Q3C Guideline for Residual Solvents.

On August 4, 2008, the FDA also issued five ICH draft guidelines for review and consultation under Step 3 of the ICH process.

The five ICH guidelines that were released are:

• Guidance for Industry: E2F Development Safety Update Report

• Guidance for Industry: International Conference on Harmonization; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonization Regions;

• Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter

• Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter

• Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter

• Annex 5: Disintegration Test General Chapter

• Guidance for Industry: Labeling OTC Skin Protectant Drug Products

• Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes