5 Questions
Which type of application is used to sell and market a new drug in the US?
NDA/BLA
Which type of application is used for the approval of generic versions of existing drugs?
ANDA
Which type of product is similar to a reference biologic product, with no clinically meaningful differences in safety, purity, and potency?
BIO-SIMILARS
What are the FDA review criteria for a new drug application or biologic license application?
Product quality, Assurance of safety, substantial evidence of effectiveness, Direction of Use
What is required for the approval of generic biologic products?
Identical: Same Active ingredient(s) & Use, Dosage form & Strength, Route of administration, Conditions of use
Test your knowledge on the various application types for pharmaceutical products in the US, including New Drug Applications (NDA), Biologic License Applications (BLA), Abbreviated New Drug Applications (ANDA), and Bio-Similars. Explore the purpose and FDA review criteria for each application type.
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