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 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(BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics” (Draft Guidance or Guidance).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April 12, 2020   Re: Docket No. FDA–2019-D-5585: FDA Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products.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…
March 27, 2020
March 18, 2020 FDA Docket No: FDA-2019-D-4964: FDA Draft Guidance on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Dear Sir/Madam: BIO thanks FDA for developing this additional guidance on demonstrating substantial evidence of effectiveness. BIO…
Patient-Take-Action
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