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

Insights

COVID-19 Pandemic, Two Years Later

Biotech Sector Unites to Aid Ukraine

To improve cardiovascular disease outcomes, connection with community is everything

News

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BIO Applauds FTC Settlement Decision

September 1, 2023

New CMS guidance a "missed opportunity" for future medical innovation, patients

June 30, 2023

White House Budget Proposal a "Costly Blow" to Patients, Innovation

March 9, 2023

BIO Submits Comments on FDA Guidance: Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials

January 3, 2023

Letters, Comments & Testimony

BIO Submits Comments on FDA Guidance: Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials

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On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which enroll pediatric participants.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,…

BIO Comments on Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments

September 23, 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…

BIO Comments on FDA Quality Metrics Reporting Program

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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