BIO Comments on FDA Draft Guidance on How to Prepare a Pre-Request for Designation (Pre-RFD)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BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, How to Prepare a Pre-Request for Designation (Pre-RFD).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 BIO says the draft guidance promotes early dialogue between sponsors seeking approval of combination products and the FDA. BIO provides additional suggestions to help clarify the draft guidance.
Dear Mr. Thune, Mr. Schumer, Mr. Johnson, and Mr. Jeffries:As President and CEO of the Biotechnology Innovation Organization (BIO), as a father and entrepreneur whose family is here today because of biotech innovation, and on behalf of the more than…
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, How to Prepare a Pre-Request for Designation (Pre-RFD).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 BIO says the draft guidance promotes early dialogue between sponsors seeking approval of combination products and the FDA. BIO provides additional suggestions to help clarify the draft guidance.