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
June 23, 2020
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the Draft Guidance for Industry “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations” (Draft Guidance or Guidance). BIO…
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(BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics” (Draft Guidance or Guidance).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April 12, 2020   Re: Docket No. FDA–2019-D-5585: FDA Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products.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…
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

Sessions available on-demand until July 11 - there's still time to register and catch up!

September 21 - 22, 2020
Online Interactive Conference