Which pathway would a sponsor use to obtain approval for a new biologic product?

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Study for the BCPS Regulatory Test. Prepare with flashcards and multiple choice questions, each question includes hints and explanations to get you ready for the exam!

Multiple Choice

Which pathway would a sponsor use to obtain approval for a new biologic product?

Explanation:
Biologics are approved through a Biologics License Application process. After early research and an Investigational New Drug filing to begin human studies, sponsors complete clinical trials to demonstrate safety and effectiveness. Then they submit a Biologics License Application to FDA for review. If FDA approves the BLA, the biologic can be marketed. The other options fit different situations: an NDA is for traditional small-molecule drugs, an IND is for starting clinical trials, and an ANDA is for generic versions of already approved small-molecule drugs.

Biologics are approved through a Biologics License Application process. After early research and an Investigational New Drug filing to begin human studies, sponsors complete clinical trials to demonstrate safety and effectiveness. Then they submit a Biologics License Application to FDA for review. If FDA approves the BLA, the biologic can be marketed. The other options fit different situations: an NDA is for traditional small-molecule drugs, an IND is for starting clinical trials, and an ANDA is for generic versions of already approved small-molecule drugs.

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