Draft guidance documents have been proposed and are issued for public comment. Each FDA draft document lists how to submit comments to the agency.
The entries below are listed in reverse chronological order by publication date.
Draft Guidance Documents
- Review and Update of Device Establishment Inspection Processes and Standards - 03/2019
- A Risk-Based Approach To Monitoring of Clinical Investigations: Questions and Answers - 03/2019
- Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank - 09/2018
- Informed Consent Information Sheet - 07/2014
- Exculpatory Language in Informed Consent - 08/2011