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, 2022
On Wednesday, December 29th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act. Existing regulations require each…
December 13, 2021
On Monday, December 13th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Q13 Continuous Manufacturing of Drug Substances and Drug Products. The draft guidance was prepared under the auspices of the International Council for Harmonisation …
November 29, 2021
On Monday, November 29th, BIO submitted comments in response to a recent FDA draft guidance for industry clarifying how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the FDA makes about new drug…
Join BIOAction
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

January 10-14, 2022
Fostering the Success of the Industry

June 13-16, 2022
The world's largest biotech partnering event