August 7, 2008
The Draft Guidance entitled, “Humanitarian Device Exemption Regulation: Questions and Answers”, is available for comment.

August 7, 2008
The ICH Draft Guidance entitled, “Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter “, is available.

August 7, 2008
The ICH Draft Guidance entitled, “Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter”, is available.

August 7, 2008
The ICH Draft Guidance entitled, “Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 5: Disintegration Test General Chapter”, is available.

August 5, 2008
The International Conference on Harmonisation (ICH) Draft Guideline entitled, “E2F Development Safety Update Report”, is available.