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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BIO Comments on Draft Guidance: Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C
January 3, 2022
BIO Comments on Draft Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products
December 13, 2021
BIO Comments on FDA Draft Guidance, Benefit-Risk Assessment for New Drug and Biological Products
November 29, 2021
"Build Back Better Act" Drug Pricing Provisions Weaken U.S. Innovation Ecosystem, Hurt Patients
November 19, 2021
Letters, Comments & Testimony
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BIO Comments on Draft Guidance: Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C
January 3, 2022
On Wednesday, December 29th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act. Existing regulations require each…
BIO Comments on Draft Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products
December 13, 2021
On Monday, December 13th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Q13 Continuous Manufacturing of Drug Substances and Drug Products. The draft guidance was prepared under the auspices of the International Council for Harmonisation …
BIO Comments on FDA Draft Guidance, Benefit-Risk Assessment for New Drug and Biological Products
November 29, 2021
On Monday, November 29th, BIO submitted comments in response to a recent FDA draft guidance for industry clarifying how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the FDA makes about new drug…
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