Pharmaceutical Application Types Quiz
5 Questions
0 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

Which type of application is used to sell and market a new drug in the US?

  • Application Type
  • NDA/BLA (correct)
  • BIO-SIMILARS
  • ANDA

    • Which type of application is used for the approval of generic versions of existing drugs?

  • BIO-SIMILARS
  • Application Type
  • ANDA (correct)
  • NDA/BLA

    • Which type of product is similar to a reference biologic product, with no clinically meaningful differences in safety, purity, and potency?

  • Generic Biologic Product
  • BIO-SIMILARS (correct)
  • NDA/BLA
  • ANDA

    • What are the FDA review criteria for a new drug application or biologic license application?

    <p>Product quality, Assurance of safety, substantial evidence of effectiveness, Direction of Use</p> Signup and view all the answers

    What is required for the approval of generic biologic products?

    <p>Identical: Same Active ingredient(s) &amp; Use, Dosage form &amp; Strength, Route of administration, Conditions of use</p> Signup and view all the answers

    More Like This

    Use Quizgecko on...
    Browser
    Open
    Browser
    Browser