Why fda conducts an advisory committee meeting with sponsor

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Reference no: EM133474471

Assignment:

To formally request approval to market a new drug in the United States, Sponsors must submit either a New Drug Application (NDA) or a Biologics License Application (BLA) to the FDA. As their names suggest, BLAs relate to biological products while NDAs generally pertain to traditional small molecule drugs. While they share the same goal of obtaining marketing approval, they also vary slightly in content and scope. In the class lecture, we explore the similarities and differences between the two marketing applications, as well as entire review process.

Student Explanations:

Explain in detail the key differences and similarities between BLA and NDA.
Explain in detail why the FDA conducts an advisory committee meeting with sponsor.
Explain what are rescue scenario sponsor can take in order to mitigate refuse to file (RTF) issued by the FDA. Provide the references.

Reference no: EM133474471

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