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BIO Response to RFI: National Biotechnology & Biomanufacturing Initiative

January 23, 2023

BIO's response to the Office of Science & Technology Policy's Request for Information concerning the National Biotechnology & Biomanufacturing Initiative

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BIO Response to RFI: National Biotechnology & Manufacturing Initiative

BIO's response to the Office of Science & Technology Policy's Request for Information concerning the National Biotechnology and Biomanufacturing Initiative

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On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which…
BIO and its members appreciate the opportunity to work with FDA to develop and align on approaches that are robust, practical, and expedite patient focused drug development. To further enhance the Guidance, we believe that a few areas would benefit…