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
April 6, 2021
On Tuesday, April 6th, BIO submitted comments on the U.S. Food and Drug Administration (FDA)’s January 2021 draft industry guidance on “Human Gene Therapy for Neurodegenerative Diseases.” In its comments, BIO stated that while the guidance covers many critical development issues for gene therapies,…
March 26, 2021
On Friday, March 26th, BIO submitted comments on the U.S. Food and Drug Administration (FDA)’s public meeting announcement titled, “Best Practices for Development and Application of Disease Progression Models.” BIO appreciates that FDA is seeking input from stakeholders on three key areas,…
December 23, 2020
On Wednesday, December 23rd, BIO submitted comments on the U.S. Food and Drug Administration (FDA)’s October 2020 public workshop titled, “New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.” In its…
Patient-Take-Action
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