21 C.F.R. 314.3 - Definitions
| Cite as | 21 C.F.R. 314.3 |
-
- This document is available in original version only for vLex customers
View this document and try vLex for 7 days - TRY VLEX
- This document is available in original version only for vLex customers
202 practice notes
-
Human drugs, biological products, and animal drugs; foreign and domestic establishment registration and listing requirements,
...pharmaceutical ingredient'' in the proposal) to make it consistent with the definition of ``drug substance'' in current Sec. 314.3 (21 CFR 314.3). Current Sec. 207.3(a)(4) states, in part, that a ``bulk drug substance * * * becomes an active ingredient,'' but does not explain what it means ......
-
Part II
...pharmaceutical ingredient'' in the proposal) to make it consistent with the definition of ``drug substance'' in current Sec. 314.3 (21 CFR 314.3). Current Sec. 207.3(a)(4) states, in part, that a ``bulk drug substance * * * becomes an active ingredient,'' but does not explain what it means ......
-
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......
-
ViroPharma, Inc. v. Hamburg, Civil Action No. 12–0584 (ESH).
...by the NDA-holder—in this case, ViroPharma—as opposed to a generic marketed by the ANDA-holder, such as defendants-intervenors. See21 C.F.R. § 314.3(b). 33.See Altana Pharma AG v. Teva Pharm. USA, Inc., 532 F.Supp.2d 666, 682 (D.N.J.2007) (concluding that there was no showing of irreparable......
Request a trial to view additional results
142 cases
-
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......
-
ViroPharma, Inc. v. Hamburg, Civil Action No. 12–0584 (ESH).
...by the NDA-holder—in this case, ViroPharma—as opposed to a generic marketed by the ANDA-holder, such as defendants-intervenors. See21 C.F.R. § 314.3(b). 33.See Altana Pharma AG v. Teva Pharm. USA, Inc., 532 F.Supp.2d 666, 682 (D.N.J.2007) (concluding that there was no showing of irreparable......
-
Takeda Pharm., U.S.A., Inc. v. Burwell, Civil Action No. 14–cv–1668 KBJ
...regarding whether or not to approve a Section 505(b)(2) application, the “right of reference” definition that the agency provides in 21 C.F.R. § 314.3 is similarly silent on the issue of whether the agency itself needs such a “right” before it can “refer to data from a previously approved a......
-
Amgen Inc. v. Hargan, Civil Action No. 17–1006 (RDM)
...An "active moiety" is "the molecule or ion ... responsible for the physiological or pharmacological action of the drug substance." 21 C.F.R. § 314.3(b) ; see Amarin Pharm. , 106 F.Supp.3d at 199.2 Available at http://www.oed.com/view/Entry/67727.3 Available at https://www.merriam-webster.co......
Request a trial to view additional results
31 firm's commentaries
-
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......
-
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 ......
-
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 ......
-
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......
Request a trial to view additional results
2 books & journal articles
-
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......
-
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)......