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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
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Insights
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WuXi Global Forum
What we learned from COVID-19 about accelerating innovation and helping patients
WuXi Global Forum
What we learned from COVID-19 about accelerating innovation and helping patients
Researcher looking at substance underneath a microscope
Payroll R&D Credit Five Years Later: Forging a New Path
News
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New “100 Days of Innovation” Blueprint Outlines Priorities To End the Pandemic, Build American Resiliency
January 27, 2021
BIO Comments on FDA’s Public Workshop on Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation
December 23, 2020
BIO Comments on FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins
November 9, 2020
Patient Reported Outcomes: BIO Comments on FDA Draft Guidance Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation
October 30, 2020
Letters, Comments & Testimony
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BIO Comments on FDA’s Public Workshop on Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation
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…
BIO Comments on FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins
November 9, 2020
On November 9, BIO submitted comments on the FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins. In the comments, BIO thanks the FDA for the opportunity to submit comments but requests that the Guidance include a discussion on the potential of generalizing information…
Patient Reported Outcomes: BIO Comments on FDA Draft Guidance Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation
October 30, 2020
October 30, 2020 Re: Docket No. FDA–2020-D-1564: FDA Draft Guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug…
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