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
BIO White Paper on FDA’s Statement of Patient Experience

In September 2017, FDA implemented the Patient Experience Data table (PED Table) to be completed by reviewers and included in NDA/BLA review documents...

Letters, Comments & Testimony
September 24, 2022
BIO and its members appreciate the opportunity to work with FDA to develop and align on approaches that are robust, practical, and expedite patient focused drug development. To further enhance the Guidance, we believe that a few areas would benefit from more explanation, examples, and references…
June 22, 2022
On Wednesday, June 22nd, BIO submitted comments on the FDA’s Quality Metrics (QM) Reporting Program. In the comments submitted, BIO stated appreciation for FDA’s intent to support a general shift toward a risk-based approach to regulation by bolstering its quality surveillance activities. However,…
December 13, 2022
On Tuesday, December 13th, BIO submitted comments in response to a recent FDA discussion paper for stakeholders on distributed manufacturing (DM) and point-of-care (POC) manufacturing. In the comments submitted, BIO commended the FDA on its collaborative approach to addressing unique challenges…
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