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Questions and Answers
Which type of application is used to sell and market a new drug in the US?
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?
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?
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?
What are the FDA review criteria for a new drug application or biologic license application?
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What is required for the approval of generic biologic products?
What is required for the approval of generic biologic products?
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