C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG › Subpart A—General Provisions

21 C.F.R. § 314.2

Purpose

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The purpose of this part is to establish an efficient and thorough drug review process in order to: (a) Facilitate the approval of drugs shown to be safe and effective; and (b) ensure the disapproval of drugs not shown to be safe and effective. These regulations are also intended to establish an effective system for FDA's surveillance of marketed drugs. These regulations shall be construed in light of these objectives.

Notes of Decisions
Cited in 8 cases (1 in the last 5 years), 1995–2024 · leading case: Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279 (D.N.H. 2009).
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Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279 (D.N.H. 2009). · cites it 7× “21, 1983) (later codified at 21 C.F.R. § 314.2 (1984)). This temporal limitation had its origins in the Drug Amendments of 1962, which “required that all drugs, both generic and pioneer, .”
In re Accutane Litig., 194 A.3d 503 (N.J. 2018). “" See 21 C.F.R. § 314.2 ; see generally , **267 21 C.”
Serono Labs Inc v. Ferring Pharm. Inc., 158 F.3d 1313 (D.C. Cir. 1998). “125 (b)(2), (3), (4) (1990); 21 C.F.R. § 314.2 (1984).] Moreover, OGD did not have a specific policy that addressed limitations on inactive ingredients in parenteral products.”
Bell v. Lollar, 791 N.E.2d 849 (Ind. Ct. App. 2003). · cites it 2× “§ 355 (d); 21 C.F.R. § 314.2 . As such, the FDCA requires drug manufacturers to obtain FDA approval before introducing new drugs into interstate commerce.”
United States v. Dulal Chatterji, 46 F.3d 1336 (4th Cir. 1995). “See 21 C.F.R. §§ 314.2 , 314.55 (1987). In order to gain approval, FDA guidelines required, inter alia, the submission of stability data from three different research batches of the drug.”
Pfizer Inc. v. Shalala, 1 F. Supp. 2d 38 (D.D.C. 1998). “What else would a generic drug be? Despite plaintiffs claims to the contrary, there is nothing in the Federal Food, Drug, and Cosmetic Act to indicate that Congress intended the FDA to develop a dosage form classification system based on a drug’s release mechanism. 10 When…”
Bartlett v. Mut. Pharm., 2009 DNH 144 (D.N.H. 2009). · cites it 6× “2 1 , 1983) (later codified at 21 C.F.R. § 314.2 (1984)). This temporal limitation had its origins in the Drug Amendments of 1962, which “required that all drugs, both generic and pioneer, .”
Bennett v. Bayer Corp. (D.N.J. 2024). “” 21 C.F.R. § 314.2 . Approval of the drug by the FDA is the final step in a multi-year process of study and testing.”
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