Legal Opinion
Lannett Co. v. U.S. Food & Drug Admin.
Court of Appeals for the D.C. Circuit
Decided October 25, 2017No. Civil Action No. 16–1350 (RBW)PublishedCited by 2 opinions
1Opinion of the Court
I. STATUTORY AND REGULATORY BACKGROUND
The Food, Drug, and Cosmetic Act (the "FDCA") provides that "[n]o person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to ... this section is effective with respect to such drug." 21 U.S.C. § 355(a). In order to obtain approval, a new drug application (a "NDA") must include, among other things, "full reports of investigations which have been made to show whether or not [the] drug is safe for use and whether [the] drug is effective in use." Id. § 355(b)(1)(A). Because…
2Cases cited34 opinions
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co.Supreme Court of the United States · 1983
- Woodford v. NgoSupreme Court of the United States · 2006
- Bennett v. SpearSupreme Court of the United States · 1997
- Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc.Supreme Court of the United States · 1975
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3Cited by2 opinions
- Cloud v. United StatesDistrict Court, District of Columbia · 2019
- State of Utah v. WalshDistrict Court, N.D. Texas · 2023