Sunday, March 14, 2010

A "see thru" FDA!

As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its interactions with regulated industry.

Posted in the March 12, 2010, Federal Register, the request for electronic or written comments has a deadline of April 12, 2010.

For this final phase, the FDA is particularly interested in comments from all interested parties on how the agency can make improvements in the following areas:

Training and education for regulated industry about the FDA regulatory process in general and/or about specific new requirements

- The guidance development process
- Maintaining open channels of communication with industry routinely and during crises
- Providing useful and timely answers to industry questions about specific regulatory issues

Electronic comments may be submitted to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852. All comments should be identified with docket number FDA-2009-N-0247.

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