Wyoming MPJE (Pharmacy Jurisprudence) Practice Exam

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Study for the Wyoming MPJE Pharmacist Licensure Exam. Utilize flashcards and multiple choice questions, each with hints and explanations. Prepare thoroughly for your exam!

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

  1. A change in production procedures

  2. Approval of a brand new drug

  3. Increase in drug price

  4. Change in drug's market demand

The correct answer is: 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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