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Product Applications (including Investigational Applications) - Draft Proposal 17

View PDF of the Product Applications (including Investigational Applications) Section (142 KB)


Summary of Public Comments


View All Product Applications (including Investigational Applications) Draft Proposals

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Draft Proposal

FDA should convene a group of internal and external stakeholders to discuss the possible uses of non-summary safety and effectiveness data from product applications, the circumstances under which it would be appropriate for sponsors to disclose non-summary safety and effectiveness data from applications submitted to FDA, and if appropriate, the format and the method by which disclosure should occur.  

Reasoning: A different balance may be struck with respect to the disclosure of non-summary safety and effectiveness information.  A blanket policy against disclosure of this type of information may not be justified because there are significant public health benefits associated with the disclosure of this information, including reducing the costs and increasing the efficiency of research. 

But given the nature of the information, other factors may weigh more strongly here.  For example, the timing of any disclosure, the potential uses for this information, the means by which disclosure would occur, and the impact disclosure may have on innovation, may lead to a different balance regarding the disclosure of non-summary safety and effectiveness data.

For these reasons, the issue would benefit from a broader discussion with relevant stakeholders to decide upon the right balance to strike.

Comments for this proposal 

(Total Received: 1)

Comment: From the reasoning in #16: "The disclosure of all data from ongoing trials or from pending marketing applications, before the company has had an opportunity to use those data to obtain approval of the product, may negatively affect product development. Disclosure of certain information, at the wrong time, may have the unintended consequence of slowing, or even stifling, product development. "
Date Submitted: 7/20/2010