Human Health

Modern biotechnology provides breakthrough products and technologies to combat debilitating diseases. Innovative medicines and cures help people lead longer, healthier lives and positively impact society by providing economic value far beyond their cost. To ensure these transformative therapies get to the people who need them, BIO is committed to advancing policies that foster innovation, fuel investment and encourage the entrepreneurial spirit that has made America the global leader in this cutting-edge field.

Tears of Sorrow, Tears of Joy
Letters, Comments & Testimony
January 3, 2023
On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which enroll pediatric participants. As planning,…
September 24, 2022
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 from more explanation, examples, and references…
June 22, 2022
On Wednesday, June 22nd, BIO submitted comments on the FDA’s Quality Metrics (QM) Reporting Program. In the comments submitted, BIO stated appreciation for FDA’s intent to support a general shift toward a risk-based approach to regulation by bolstering its quality surveillance activities. However,…
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