February 8, 2010
The Guidance for Industry: Use of Bayesian Statistics in Medical Device Clinical Trials is available.

February 8, 2010
The Guidance for Industry: Contents of Complete Submission for Evaluation of Proprietary Names is available.

January 21, 2010
An ICH Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals is available.

January 20, 2010
The draft Guidance for Industry: Heart Valves – Investigational Device Exemption and Premarket Approval Applications is available.

January 13, 2010
The draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval is available.

January 8, 2010
The draft Guidance for Industry: Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products is available.

January 6, 2010
The Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products is available.