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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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New CMS guidance a "missed opportunity" for future medical innovation, patients
June 30, 2023
White House Budget Proposal a "Costly Blow" to Patients, Innovation
March 9, 2023
BIO Submits Comments on FDA Guidance: Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials
January 3, 2023
BIO Comments on Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
September 23, 2022
Letters, Comments & Testimony
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BIO Submits Comments on FDA Guidance: Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials
January 3, 2023
On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which enroll pediatric participants. As planning,…
BIO Comments on Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
September 23, 2022
BIO and its members appreciate the opportunity to work with FDA to develop and align on approaches that are robust, practical, and expedite patient focused drug development. To further enhance the Guidance, we believe that a few areas would benefit from more explanation, examples, and references…
BIO Comments on FDA Quality Metrics Reporting Program
June 22, 2022
On Wednesday, June 22nd, BIO submitted comments on the FDA’s Quality Metrics (QM) Reporting Program. In the comments submitted, BIO stated appreciation for FDA’s intent to support a general shift toward a risk-based approach to regulation by bolstering its quality surveillance activities. However,…
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