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Approved list of biological agents

Found 2 free book(s)

Objectives Roles & Responsibilities of the Sponsor

ccrod.cancer.gov

• Submit Biological License Application (BLA) to FDA for biologics Investigational New Drug Application (IND) • Sponsor submits to the FDA • Descriptive notification of intention to conduct clinical studies with an investigational drug or biologic • Allows for transportation of product (non-approved drug) across state lines IND Sections

  Biological, Roles, Responsibilities, Approved, Sponsor, Roles amp responsibilities of the sponsor

Vaccine Excipient Summary

www.cdc.gov

list of ingredients or excipients. A table listing vaccine excipients and media by excipient is published by the Institute for Vaccine Safety at Johns Hopkins University, and can be found at

  Lists

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