2022—Subsec. (a). Pub. L. 117–328 inserted “, or section 262(a) of title 42, that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness” before period at end.
2016—Pub. L. 114–255 designated existing provisions as subsec. (a), inserted heading, substituted “the first application” for “any application”, and added subsec. (b).
Pub. L. 112–144, title VIII, § 802(b),