What does ANDA stand for?

Unlock all questions

This demo includes only 20 questions. Upgrade to access hundreds of questions, flashcards, exam simulations, and disable ads.

Full question bankExam simulationsFlashcards
From $24.99Unlock all

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

What does ANDA stand for?

Explanation:
Abbreviated New Drug Application is the process used to bring a generic drug to the U.S. market. The term “abbreviated” means the pathway doesn’t require repeating all the original safety and efficacy studies done for the brand-name drug. Instead, a generic developer must show that the product is bioequivalent to the reference listed drug and submit appropriate manufacturing and labeling information. This relies on the data from the original drug while aiming for the same clinical effect. The other options aren’t standard FDA terms for this pathway, so they don’t fit as the correct expansion of ANDA.

Abbreviated New Drug Application is the process used to bring a generic drug to the U.S. market. The term “abbreviated” means the pathway doesn’t require repeating all the original safety and efficacy studies done for the brand-name drug. Instead, a generic developer must show that the product is bioequivalent to the reference listed drug and submit appropriate manufacturing and labeling information. This relies on the data from the original drug while aiming for the same clinical effect. The other options aren’t standard FDA terms for this pathway, so they don’t fit as the correct expansion of ANDA.

More Multiple Choice Questions
Subscribe

Get the latest from Examzify

You can unsubscribe at any time. Read our privacy policy