§357. Qualification of drug development tools — Inbound Citations

Citations to 21 U.S.C. § 357 as a whole

• 21 U.S.C. § 321(ff)(3)(B)(i)

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  (i) an article that is approved as a new drug under section 355 of this title, certified as an antibiotic under section 357 of this title, or licensed as a biologic under section 262 of title 42, or
• 21 U.S.C. § 355(v)(1)(B)(ii)

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  (ii) An antibiotic drug described in this clause is an antibiotic drug that was the subject of an application approved by the Secretary under section 357 of this title (as in effect before November 21, 1997).
• 21 U.S.C. § 355(v)(2)(B)(ii)

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  (ii) An antibiotic drug described in this clause is an antibiotic drug that was the subject of 1 or more applications received by the Secretary under section 357 of this title (as in effect before November 21, 1997), none of which was approved by the Secretary under such section.
• 21 U.S.C. § 379j–41(1)(A)

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  (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
• 21 U.S.C. § 379r(d)(1)

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  (1) In the case of a drug described in subsection (a)(1) that is not the subject of an application approved under section 355 of this title or section 357 of this title (as in effect on the day before November 21, 1997) or a final order under section 355h of this title by the Secretary establishing conditions under which the drug is generally recognized as safe and effective, subsection (a) shall apply only with respect to a requirement of a State or political subdivision of a State that relates to the same subject as, but is different from or in addition to, or that is otherwise not identical with—

  (A) a regulation or order in effect with respect to the drug pursuant to a statute described in subsection (a)(2); or

  (B) any other requirement in effect with respect to the drug pursuant to an amendment to such a statute made on or after November 21, 1997.