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Congress Forces FDA to Evaluate Some 505(b)(2) Products for Therapeutic Equivalence Listing in Orange Book | Locke Lord LLP
For nearly forty years, the Food and Drug Administration (“FDA”) has required applicants seeking approval of “generic” or “branded generic” drugs under section 505(b)(2) of the Federal.
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Drug administration
Federal food
Cosmetics act
Citizen petition
Drug omnibus reform act
Drugs can obtain
Therapeutic equivalence
Will review
Eligible drug
Ultimate effect
Drug makers
Abbreviated new drug application
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