21 C.F.R. § 320.1
Definitions
The definitions contained in § 314.3 of this chapter apply to those terms when used in this part.
Notes of Decisions
Cited in 50
cases, 1978–2016 · leading case: Schering Corp. v. Food & Drug Admin., 51 F.3d 390 (3rd Cir. 1995).
Schering Corp. v. Food & Drug Admin., 51 F.3d 390 (3rd Cir. 1995). “The FDA regulation at issue, codified at 21 C.F.R. § 320.1 (e) (1994), was promulgated in 1992 to implement the bioequivalence requirements for generic drugs approved under the abbreviated application procedure.”
Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (2013). “§§ 355 (j)(2)(A)(ii) - (v) and (8)(B) ; 21 C.F.R. § 320.1 (c). Consequently, the Court of Appeals was correct to recognize that "Mutual cannot legally make sulindac in another composition.”
Schrock v. Wyeth, Inc., 727 F.3d 1273 (10th Cir. 2013). “§§ 355 (j)(2)(A)(ii)-(v) and (8)(B); 21 C.F.R. § 320.1 (c)). Under Bartlett , a claim that a generic drug manufacturer’s product is unfit for its intended use or unreasonably dangerous is one that would impose a duty to alter the composition of that drug.”
Pfizer Inc v. Shalala, Donna E., 182 F.3d 975 (D.C. Cir. 1999). “§ 355QX8); 21 C.F.R. § 320.1 (e). To gain approval as a “pharmaceutical equivalent,” 21 C.”
United States v. Baxter Healthcare Corp., & Glaxo Specialties, Inc., a Corp., Intervenor/defendant-Appellant, 901 F.2d 1401 (7th Cir. 1990). “The Supreme Court’s use of that term may have been drawn from 21 C.F.R. § 320.1 (e), which carried a similar definition.”
Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (Cal. Ct. App. 2008). “3 (Foster); see 21 C.F.R. § 320.1 (e) (2003).) 4 “The PDR is an annual publication compiling product information about pharmaceuticals.”
Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013). “§§355 (j)(2)(A)(ii)–(v) and (8)(B); 21 CFR §320.1 (c). Conse- quently, the Court of Appeals was correct to recognize that “Mutual cannot legally make sulindac in another composi- tion.”
Tri-Bio Labs., Inc. v. United States of Am. & Food & Drug Admin., 836 F.2d 135 (3rd Cir. 1988). “See also 21 C.F.R. § 320.1 (e) (1987). 4 . A citizen’s petition to the FDA to issue, amend or revoke an agency regulation or take other administrative action is authorized by 21 C.”
In Re Fosamax (Alendronate Sodium) Prods. Liab. Litig., 751 F.3d 150 (3rd Cir. 2014). “” 21 C.F.R. § 320.1 (e). 3 . This is, necessarily, a general and incomplete summary of a complicated regulatory scheme.”
Utts v. Bristol-Myers Squibb Co., 226 F. Supp. 3d 166 (S.D.N.Y. 2016). “§ 355 (j)(2)(A)(ii)-(v) and (8)(B); 21 C.F.R. § 320.1 (c)). If the generic manufacturer were to change the composition of the generic drug, “the altered chemical would be a new drug that would require its own NDA to be marketed in interstate commerce.”
A.L. Pharma, Inc. v. Donna E. Shalala, 62 F.3d 1484 (D.C. Cir. 1995). “21 C.F.R. § 320.1 (e) (1994); compare 21 U.”
Mission Pharmacal Co. v. Virtus Pharm., LLC, 23 F. Supp. 3d 748 (W.D. Tex. 2014). “§ 355 (j)(2)(A)(i)-(viii); 21 C.F.R. § 320.1 (c), (e); Axcan Scandipharm.”
— 21 C.F.R. § 320.1(c) — 1 case
Pharm. Mfrs. Ass'n v. Kennedy, 471 F. Supp. 1224 (D. Maryland 1979).
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