Approval of an NDA and an ANDA
| Currency | Current through May 31, 2023 |
| Citation | 21 C.F.R. §314.105 |
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1 books & journal articles
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Examining Subject-Matter Jurisdiction over Declaratory Judgment Claims Filed in Combination with Patent Infringement Claims under Section 271(e)(2)(A)
...1992). 22. Abbott Labs., 934 F. Supp. at 938–39. 23. Id. 24. Id. at 939. 25. Id. at 938. FDA approval of ANDAs is governed pursuant to 21 C.F.R. § 314.105. 26. Id. dor54588_08_ch08_149-174.indd 153 5/5/16 5:35 PM 154 CHAPTER 8 It makes little sense, and thus we assume would be inconsistent ......
