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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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BIO
Marking Rare Disease Day 2021
drugs
How long does it take to get a drug approved?
WuXi Global Forum
What we learned from COVID-19 about accelerating innovation and helping patients
News
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BIO Comments on FDA’s Draft Guidance on Human Gene Therapy for Neurodegenerative Diseases
April 6, 2021
BIO Comments on FDA’s Public Meeting Announcement: Best Practices for Development and Application of Disease Progression Models
March 26, 2021
BIO Welcomes Collaboration With New HHS, USTR Leaders
March 18, 2021
New “100 Days of Innovation” Blueprint Outlines Priorities To End the Pandemic, Build American Resiliency
January 27, 2021
Letters, Comments & Testimony
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BIO Comments on FDA’s Draft Guidance on Human Gene Therapy for Neurodegenerative Diseases
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,…
BIO Comments on FDA’s Public Meeting Announcement: Best Practices for Development and Application of Disease Progression Models
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,…
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…
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