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FDA Issues Six Draft Guidance Documents
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On August 6, the FDA released a guidance entitled Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States.
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- Guidance for Industry: International Conference on Harmonization; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonization Regions;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 5: Disintegration Test General Chapter
- Guidance for Industry: Labeling OTC Skin Protectant Drug Products
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