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BIO Comments on FDA Draft Guidance on How to Prepare a Pre-Request for Designation (Pre-RFD)

April 13, 2017

BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, How to Prepare a Pre-Request for Designation (Pre-RFD).

BIO supports continued improvements to the review process of combination products. BIO says the draft guidance promotes early dialogue between sponsors seeking approval of combination products and the FDA. BIO provides additional suggestions to help clarify the draft guidance.

Download Full Comments Below
BIO Letter. Pre-RFD
Click the link below for full comments
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