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Archive for November, 2009

Tell Us Your Ideas: How Should FDA Inform the Public About Inspection Results

November 21, 2009 41 comments

FDA conducts many inspections. A completed Form FDA-483 lists observations made during an inspection of a firm. Responding to Freedom of Information Act (FOIA) requests for these reports of inspectional observations, however, often takes a lot of time because of the need to redact non-public information, such as trade secret and confidential commercial information, from the inspection report.

FDA seeks input on whether inspection reports should be re-designed to separate out a summary or key findings page that could be made available to the public quickly. Disclosure of full inspectional observation reports would still require the same review for non-public information as it does now.

Does this sound like a good idea? If so, what would be key points to be included in the summary page? What, if any, other ways can the agency use to provide results of inspections to the public quickly?

We look forward to your feedback.

Transparency Task Force

Watch and Comment on the Task Force’s Second Public Meeting

November 2, 2009 1 comment

The second public meeting on transparency can be viewed via live webcast. To view the live webcast click on this link.

The link will not be active until November 3, 2009, at 8:30 AM ET. The webcast of the meeting will also be archived on the transparency task force website and can be viewed there 24 hours after the meeting. For details on the day's events, please view the meeting agenda, available here.

Afia Asamoah, Public Meeting Coordinator

Ground Rules for November 3 Public Meeting on Transparency

November 2, 2009 13 comments

- The purpose of this public meeting is to receive in-depth comments on three specific issues related to transparency at FDA. Comments should be limited to those issues.

- Each issue will be discussed by a stakeholder panel. Participants on each panel will discuss a hypothetical case study about the issue. Transparency task force members may ask questions of the panel following the discussion.

- During the public comment period, audience members may comment for up to 2 minutes each about the case studies.
- We are looking forward to a respectful discussion and exchange of ideas.

- Comments should be made only when at a microphone and you have been recognized by the Chair of the meeting.

- Do not share or reveal information you would not want to be public.

- In addition to the public meeting, there are other ways to provide comments to the task force. You can post comments to this blog, submit written comments to the Division of Dockets Management, or submit electronic comments to Docket No. FDA-2009-N-0247 at www.regulations.gov. Information about submitting comments to the task force can be found in the Federal Register notice. We look forward to your participation at the public meeting on November 3.

Afia Asamoah, Public Meeting Coordinator

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