§4.2. How does FDA define key terms and phrases in this subpart? — Inbound Citations
21 C.F.R. § 4.2
Statutory Authority
Cited by 2 regulations in release Current.
Citations to 21 C.F.R. § 4.2 as a whole
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Abbreviated new drug application (ANDA) has the same meaning given the term “abbreviated application” in § 314.3(b) of this chapter.
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The definitions of terms in section 804 of the Federal Food, Drug, and Cosmetic Act apply to the terms used in this part, if not otherwise defined in this section. The following definitions apply to this part: