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Posts Tagged ‘FDA Basics for Industry’

Transparency to Regulated Industry: Communicating with Sponsors During FDA’s Review of the Product Application

April 2, 2010 4 comments

The Task Force is collecting information on how to improve FDA's transparency to regulated industry.  We held three listening sesions with members of regulated industry on January 21, 27, and 28.  Transcripts and summaries of those listening sessions are available online and we are seeking comments from the public on the issues raised in those sessions, or other suggestions related to FDA's transparency to regulated industry. 

Our next question is:

What information, if any, should FDA provide to sponsors during the agency's review of the sponsor's product application?

We look forward to your ideas.

Transparency Task Force

Transparency to Regulated Industry: How Can FDA Improve Its Guidance Development Process?

March 26, 2010 29 comments

The Task Force is collecting information on how to improve FDA's transparency to regulated industry.  We held three listening sesions with members of regulated industry on January 21, 27, and 28.  Transcripts and summaries of those listening sessions are available online and we are seeking comments from the public on the issues raised in those sessions, or other suggestions related to FDA's transparency to regulated industry. 

Our next question is:

What changes, if any, should FDA make to its guidance development process?

We look forward to your ideas.

Transparency Task Force

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