Wyoming MPJE (Pharmacy Jurisprudence) Practice Exam

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.