The FDA is soliciting comments on the following draft guidance documents:
- “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format'' -- comments will be accepted until June 1, 2009.
- “Process Validation: General Principles and Practices” – the comment period has been reopened until March 16, 2009.
- The FDA has issued several draft guidance documents prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The first draft document addresses Nonclinical Evaluation for Anticancer Pharmaceuticals. Three draft documents address Evaluation and Recommendation of Pharmacopoeial Texts, covering chapters on Uniformity of Dosage Units, Dissolution Test, and Sterility Tests. The comment deadline for each of these guidance documents is April 20, 2009.