· 4/26/2013
AstraZeneca Pharmaceuticals LP v. Food & Drug Administration
Citations
- 404 U.S. App. D.C. 339
- 713 F.3d 1134
- 2013 WL 1776473
- 2013 U.S. App. LEXIS 8476
How courts have described this case
Verbatim parenthetical descriptions written by other courts when citing this decision. Ranked by citation-network relevance.
- applying Chevron to an FDA statutory interpretation contained in a letter decision
- applying Chevron to an FDA statutory interpretation contained in a letter decision
- “ANDAs need not include new clinical studies 2 demonstrating . . . safety or efficacy, but must propose the same basic labeling as approved for the pioneer drug.”
- applying Chevron to FDA’s letter decision interpreting the FDCA
Source: CourtListener parenthetical corpus (CC0).
Judges: Rogers, Tatel, Sentelle
Read full opinion on CourtListenerSourced from CourtListener / Free Law Project (CC0).
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