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
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...

Letters, Comments & Testimony
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On Monday, November 29th, BIO submitted comments in response to a recent FDA draft guidance for industry clarifying how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory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…
November 8, 2021
On Monday, November 8th, BIO submitted comments to the FDA’s draft guidance on Nonclinical Biodistribution Considerations for Gene Therapy Products. In the comment letter, BIO expressed appreciation for the Agency’s decision to put forth a draft guidance that was developed under the auspices of the…
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…
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