This post was written by Paul Sheives.
The FDA is seeking comments on a report entitled “FDA Transparency Initiative: Improving Transparency to Regulated Industry.’’ Based on previous input from regulated industry, the report provides a series of action items relating to ensuring better communication with regulated industry, a more transparent review process, and improved communications with importers. In addition, the report includes five draft proposals, including: (1) timelines for the development of guidance documents; (2) posting on the FDA web site a list of presentations given by FDA employees to external audiences; (3) informing submitters if an appeal request will be reviewed by the FDA Commissioner and when a decision may be expected; (4) reviewing existing procedures to evaluate importers or their agents who file information electronically about products offered for import; and (5) initiating a planning process to develop a web-based system with information about importing requirements. FDA is accepting written comments on the draft report until March 8, 2011; for more information.