642 F.Supp.2d 10 (D.D.C. 2009), C. A. 09-1511 (RMU), Astellas Pharma US, Inc. v. Food and Drug Admin.
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642 F.Supp.2d 10 (D.D.C. 2009), C. A. 09-1511 (RMU), Astellas Pharma US, Inc. v. Food and Drug Admin.
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- US Code - 5 U.S.C. § 702 Right of Review
- Code of Federal Regulations - Refusal to approve an ANDA
- Code of Federal Regulations - Definitions
- Code of Federal Regulations - Types of evidence to measure bioavailability or establish bioequivalence
- Federal Cases - National Treasury Employees Union v. Yeutter