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New Drug Applications (NDA) vs. Biologics License Applications (BLA)

There are many similarities between the new drug application (NDA) and the biologics license application (BLA). Both have fast-track designation and special protocol assessment; require financial disclosure; share labeling and advertising regulations; have pediatric study requirements and waivers, accelerated approval and orphan exclusivity.

NDAs and BLAs have regulations, guidance documents and fall under the Prescription Drug User Fee Act. Patent and pediatric exclusivity are unique to NDAs, and content and filing criteria regulations are more detailed. BLAs have more regulations related to the manufacturing facility; the product and the facility must meet certain standards prior to being licensed. Before approval, the facility must pass inspection and a compliance check and must complete a method validation review.

a group of scientists examine a petri dish
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