abbreviated new drug application

(1) The term “abbreviated new drug application”— (A) means an application submitted under section 355(j) of this title , an abbreviated application submitted under section 357 of this title (as in effect on the day before November 21, 1997 ), or an abbreviated new drug application submitted pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984; and (B) does not include an application— (i) for a positron emission tomography drug; or (ii) submitted by a State or Federal governmental entity for a drug that is not distributed commercially.


21 USC § 379j-41(1)

Scoping language

For purposes of this subpart
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