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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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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...

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Insights
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How Drug Price Controls End Up Hurting Patients
How Drug Price Controls End Up Hurting Patients
Researcher
An Update on Clinical Development and Therapeutic Company Funding and Deals
Good Trouble for Good Medicine
Good Trouble for Good Medicine
News
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Biden Drug Plan Adds Barriers to Seniors Accessing Lifesaving Medicines
August 12, 2021
BIO Submits Comments on FDA Manufacturing, Supply Chain, and Inspections Guidances & Report
July 16, 2021
BIO Comments on FDA’s Draft Guidance on Human Gene Therapy for Neurodegenerative Diseases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
Letters, Comments & Testimony
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BIO Submits Comments on FDA Manufacturing, Supply Chain, and Inspections Guidances & Report
July 16, 2021
On Wednesday, July 14th, BIO submitted comments on FDA’s Guidances: 1) Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance; 2) Updated Manufacturing, Supply Chain, and Drug and Biological Product Inspections…
BIO Comments on FDA’s Draft Guidance on Human Gene Therapy for Neurodegenerative Diseases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,…
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