Sec. 393. Conditions of use for biosimilar biological products
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/bill/116/hr/19/ih/section-393A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 351(k)(2)(A)(iii) of the Public Health Service Act ( 42 U.S.C. 262(k)(2)(A)(iii) ) is amended— in subclause (I), by striking ; and and inserting a semicolon; in subclause (II), by striking the period and inserting ; and ; and by adding at the end the following: may include information to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product. .
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Sec. 393
Conditions of use for biosimilar biological products
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