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
April 20, 2020
Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics” (Draft Guidance or Guidance). …
April 17, 2020
April 12, 2020   Re: Docket No. FDA–2019-D-5585: FDA Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products.   Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to…
March 27, 2020
March 18, 2020 FDA Docket No: FDA-2019-D-4964: FDA Draft Guidance on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Dear Sir/Madam: BIO thanks FDA for developing this additional guidance on demonstrating substantial evidence of effectiveness. BIO…
Patient-Take-Action
Become an Advocate for Biotechnology

Sign-up to join BIOAction, BIO's grassroots advocacy program. You will be notified about relevant policy issues where we need you to contact your lawmaker.

BIO Advocacy Toolkit

We’ve made it easier for you to access information and share content about biotechnology and prescription medicines. Learn more about dozens of topics and then share information you discover on Twitter, Facebook, and LinkedIn.

BIO Advocate Toolkit
Upcoming BIO Events

Online and Live
July 22-26, 2020
Taipei, Taiwan

New virtual event format for the 2020 BIO International Convention. 
June 8-12, 2020

September 21 - 24, 2020
Raleigh, North Carolina