We Want Your Feedback: Public Comment Period Ends July 20 (Feature Topic 3: Product Applications)
On May 19, the Transparency Task Force released 21 draft proposals about information FDA should consider making available to the public. (see previous blog post). The time to provide the Task Force with your feedback on these draft proposals ends next Tuesday, July 20.
The third topic being featured for your input is Product Applications. For example, some of the draft proposals for comment would allow FDA to:
- Better explain FDA decisions — One proposal for comment is to allow FDA to explain when the agency declines to approve medical products. Click here to comment on and rate the proposal. You can read the draft proposal, FDA's reason for the proposal, and other comments submitted so far.
- Provide more data to doctors and patients — A proposal would allow FDA to release summary data on safety and effectiveness from medical product applications when doing so would clear misconceptions or promote public health. Click here to comment on and rate the proposal. You can read the draft proposal, FDA's reason for the proposal, and other comments submitted so far.
- Support innovation for rare diseases — A proposal would allow FDA to explain that an abadoned application for an orphan drug could represent a significant therapeutic advance. Click here to comment on and rate the proposal. You can read the draft proposal, FDA's reason for the proposal, and other comments submitted so far.
- You can view and comment on all of the draft proposals about product applications here.
The Task Force is asking for your feedback on the content of the draft proposal and on which proposal(s) should be given priority.
The entire report is available on the FDA Web site. Visit the web site, read the report, and comment there about any of the 21 draft proposals. You can also submit a comment here.
We look forward to your input.
Afia Asamoah
FDA Transparency Initiative Coordinator
To slash the risks of diabetes, heart-attacks, strokes and cancer, one must must possess healthy choices of healthy diet, physical activity, avoid smoke and obesity.
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James
I am very impressed by the discussion so far. I do have a major concern though. We are encouraging people to cycle more. But in the drive to encourage health and wellbeing, bicycle safety is paramount. Before we entice people of all ages into the streets on their bicycles, how can we ensure cyclists are safer on the roads?