21 C.F.R. §314.3 - Definitions
| Cite as | 21 C.F.R. §314.3 |
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162 cases
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Neurelis, Inc. v. Aquestive Therapeutics, Inc., D077984, D078186
...to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of drug action." (21 C.F.R. § 314.3 (2021).)3 Neurelis alleges that, at the time of the filing of Aquestive's Form S-1, Aquestive had not yet completed any clinical trials for L......
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In re Incretin-Based Therapies Prods. Liab. Litig., Case No.: 13-md-2452-AJB-MDD
...events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA. 21 C.F.R. § 314.3. Again, a manufacturer "cannot propose a change that is not based on reasonable evidence." Albrecht , 139 S. Ct. at 1679. The proposed chan......
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GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., 2018-1976, 2018-2023
...meaning—namely, that a patent or regulatory exclusivity stands in the way of final approval. 21 U.S.C. § 355(j)(5)(B)(iv)(II)(dd)(A) ; 21 C.F.R. § 314.3(b) ; see J.A. 10533. In other words, this "approval" had conditions.With that in mind, the question remains: what is there in this press r......
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Apotex, Inc. v. Daiichi Sankyo, Inc., s. 2014–1282
...that “could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug”); 21 C.F.R. §§ 314.3, 314.53. The first, U.S. Patent No. 5,616,599, covers the active ingredient of the drug, olmesartan medoxomil. It expires on April 25, 2016, bu......
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31 firm's commentaries
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Requirements, Benefits, And Possible Consequences Of Listing Patents In FDA's Orange Book
...Drug product patents include those "that claim the drug product . . . that is described in the pending or approved NDA." Id. (citing 21 C.F.R. § 314.3). FDA regulations define "drug product" as "a finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, gene......
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No Ifs, Ands Or Butts – Preemption Gutts, Rebutts, and Shutts Down Utts
...given the scope of the FDA’s “changes being effected” exception to preemption recognized in Wyeth v. Levine, 555 U.S. 555 (2009). See 21 C.F.R. §314.3(b) (known as the “CBE” regulation for drugs – note, there are similar CBE regulations for devices and biologics; we’ve discussed the device ......
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No Ifs, Ands Or Butts Preemption Gutts, Rebutts, And Shutts Down Utts
...given the scope of the FDA's "changes being effected" exception to preemption recognized in Wyeth v. Levine, 555 U.S. 555 (2009). See 21 C.F.R. §314.3(b) (known as the "CBE" regulation for drugs - note, there are similar CBE regulations for devices and biologics; we've discussed the device ......
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Know the Rules! FDA’s New Regulations Change Responsibilities For ANDA Filers
...be extended to the next business day. The amendments to the regulations now clarify both issues. In amending the Definition section of 21 C.F.R. § 314.3, FDA has stated that it will no longer issue “acceptance for filing letters” and instead will be issuing “paragraph IV acknowledgement let......
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2 books & journal articles
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Initiating Litigation
...applied to Hatch-Waxman patent suits, and dismissed the plaintiff for lack of standing. Id. at 399. 6. 35 U.S.C. § 271(e)(2)(A). 7. 21 C.F.R. §§ 314.3(b) & 314.50(a)(1) & 314.94(a)(1). 8. 21 C.F.R. § 314.50(a)(5). In In re Rosuvastatin Calcium Patent Litigation, the court held that a subsid......
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Too good to last? Will the FDA's proposed rule put an end to generic drug preemption under Mensing and Bartlett?
...at 430. (44) Id. at 436 (emphases original). (45) Mensing, 131 S.Ct. at 2573. (46) Id. at 2574. (47) Id. (48) Id. at 2574, n. 2. (49) 21 C.F.R. 314.3. The application submitted by a generic drug under this statutory scheme is referred to as an abbreviated new drug application ("ANDA"). (50)......