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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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Child Patient
New hope for rare disease patients with founding of non-profit with for-profit model
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
News
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BIO Comments on FDA Guidance on Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials
June 12, 2022
BIO Comments on FDA Guidance: Use of Whole Slide Imaging in Nonclinical Toxicology Studies
June 7, 2022
BIO Comments on FDA Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates
May 9, 2022
BIO Comments on Upcoming ODAC Pediatric Oncology Subcommittee Meeting
April 27, 2022
Letters, Comments & Testimony
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BIO Comments on FDA Guidance on Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials
June 12, 2022
On Monday, June 13th, BIO submitted comments in response to a recently published FDA draft guidance providing recommendations to sponsors on developing a Race and Ethnicity Diversity Plan to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic…
BIO Comments on FDA Guidance: Use of Whole Slide Imaging in Nonclinical Toxicology Studies
June 7, 2022
On Tuesday, June 7th, BIO submitted comments in response to the FDA’s draft guidance concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies conducted in compliance with GLP regulations. Importantly,…
BIO Comments on FDA Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates
May 9, 2022
On Monday, May 9th, BIO submitted comments in response to the FDA’s recent draft guidance on Clinical Pharmacology Considerations for Antibody-Drug Conjugates. In the comments submitted, BIO acknowledged the challenge FDA faces in creating a regulatory guidance that is comprehensive yet adaptable,…
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