FDA Continues Transparency Effort


The FDA “Transparency Task Force” (what a name) will hold a public meeting announcing: “FDA Transparency Task Force to Hold 2nd Public Meeting on Ensuring That Agency Information is Useful, Understandable, Accessible.” For more information on the November 3rd meeting go to the FDA website at http://www.fda.gov. FDA says the topics for the meeting are:

1. Early communication about emerging safety issues concerning FDA-regulated products

2. Disclosure of information about product applications that are abandoned, i.e., no work is being done or will be undertaken to have the application approved, or withdrawn by the applicant before approval

3. Communication of agency decisions about pending product applications.

Unfortunately, the organizations that know how to mobilize articulate representatives for public FDA meetings like this are not always the organizations with FDA’s best interests at heart. FDA is a large, complex organization and it can be a little intimidating to think about speaking in public about any specific concerns. Also, some of us don’t live within driving distance of Washington, DC (its on the wrong coast). FDA has set up a “Transparency Blog” where it might be easier to make a contribution. FDA is actually doing a lot of listening these days so please, speak your mind, you just might have something useful and understandable to say.

Link to the FDA Transparency Blog: on Blogroll under FDA Transparency Blog

UPDATE: The FDA issued a press release on 12 March 2010 that said in part:

“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.”

It continues:

“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.”

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

Read the FDA Press Release:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm204236.htm

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