Drug Development, Review & Lifecycle Management

Before a therapy is approved for delivery to patients a lot of hard work and research goes into demonstrating that the therapy is safe, effective, and high quality. We work to promote a regulatory environment that supports safe and efficient development and approval of therapies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place.

Drug Development and Clinical Trial Process
Drug Development and Clinical Trials Process
Letters, Comments & Testimony
November 13, 2019
The Biotechnology Innovation Organization provided comments to the Treasury Department and Internal Revenue Service on proposed regulations under Section 382 with respect to the built-in gain and built-in loss rules of Section 382(h).
October 30, 2019
In a recent letter, BIO’s Jim Greenwood commended Representative Steil (R-WI) for introducing the “Helping Startups Continue to Grow Act,” which extends the exemption afforded to Emerging Growth Companies under the JOBS Act from certain executive compensation, financial, and other disclosure…
November 4, 2019
In a letter to Chairman Grassley (R-IA) and Ranking Member Wyden (D-OR), the leaders of the Senate Finance Committee, state biotech associations warn that the Committee’s proposed redesign of Medicare Part D puts new, innovative treatments for patients at risk. “For many small, innovative…
Patient-Take-Action
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