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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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Biotech Leaders: Trust Science to Eradicate Covid-19
Biotech Leaders: Trust Science to Eradicate Covid-19
Beyond Imaagination
Can Cows Help Treat COVID-19?
Beyond Imaagination
Targeting “Undruggable” Diseases
News
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Pediatrics: BIO Comments on FDA Draft Guidance Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products – Content and Format
September 28, 2020
Gov. Hogan, Novavax’ Erck, & BIO’s Dr. McMurry-Heath Toured Novavax Labs and Discussed Progress on COVID-19 Vaccine
September 24, 2020
BIO Signs Coalition Letter In Support of the IGNITE American Innovation Act
August 5, 2020
Data Modernization: BIO Comments on Modernizing the Food and Drug Administration’s Data Strategy
July 30, 2020
Letters, Comments & Testimony
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Pediatrics: BIO Comments on FDA Draft Guidance Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products – Content and Format
September 28, 2020
September 27, 2020 Re: Docket No. FDA-2014-D-1551:  FDA Draft Guidance, Pregnancy, Lactation, and Reproductive Potential:  Labeling for Human Prescription Drug and Biological Products – Content and Format. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food…
BIO Signs Coalition Letter In Support of the IGNITE American Innovation Act
August 5, 2020
We write as a coalition of advocates for the startup ecosystem to voice our strong support for the IGNITE American Innovation Act, legislation to support startups through the economic crisis by allowing companies to monetize tax assets generated through a focus on researching and producing products…
Data Modernization: BIO Comments on Modernizing the Food and Drug Administration’s Data Strategy
July 30, 2020
July 30, 2020 Re: Docket No. FDA–2019-D-5799: FDA’s Public Meeting, Modernizing the Food and Drug Administration’s Data Strategy. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments…
Patient-Take-Action
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