FDA Guidance Documents
The FDA is accepting comments on the following new draft guidance documents for industry:
- “Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation.” To be considered in drafting the final guidance, comments must be received by December 14, 2009.
- “Microbiological Data for Systemic Antibacterial Drug Products Development, Analysis, and Presentation”; comments are due December 16, 2009.
- “Clinical Considerations for Therapeutic Cancer Vaccines”; the comment deadline is December 17, 2009.
- “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses”; comments are due December 8, 2009.
In addition, the FDA recently has issued a number of final guidance documents, including the following:
- “End-of-Phase 2A Meetings”;
- “Considerations for Allogeneic Pancreatic Islet Cell Products”; and
- “Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.”
