Ace the Wyoming MPJE 2026 – Rock Your Pharmacy Jurisprudence Skills!

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What triggers the submission of a Supplemental New Drug Application (SNDA)?

A change in production procedures

A Supplemental New Drug Application (SNDA) submission is triggered by a change in production procedures. When a pharmaceutical company intends to make changes to the manufacturing process of a drug that is already approved by the FDA, they must submit an SNDA to seek approval for these modifications. The other options of the approval of a brand new drug, an increase in drug price, or a change in the drug's market demand do not directly require an SNDA submission.

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Approval of a brand new drug

Increase in drug price

Change in drug's market demand

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