21 CFR 316.3 - Definitions
| Cite as | 21 CFR 316.3 |
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30 practice notes
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Eagle Pharm., Inc. v. Azar, No. 18-5207
...as a previously approved drug if it shares the same "active moiety"—the same active ingredient—and "is intended for the same use," 21 C.F.R. § 316.3(b)(14)(i). The FDA has also determined, however, that, "if the subsequent drug can be shown to be clinically superior to the first drug"—despi......
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The Statutory and Regulatory Scheme
...sponsor must submit its application (or supplement) for pediatric exclusivity 15 months prior to expiration of adult exclusivity. 55. 21 C.F.R. § 316.3(b)(13)(ii). 56. 21 C.F.R. § 316.3(b)(3). 57. 21 U.S.C. § 355a. 58. 21 U.S.C. § 355a(c). 59. Regarding “off-label” uses, it has been notably......
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Depomed, Inc. v. U.S. Dep't of Health & Human Servs., Civil Action No. 12–cv–1592 KBJ
...“that if the subsequent drug can be shown to be clinically superior to the first drug, it will not be considered to be the same drug.” 21 C.F.R. § 316.3(b)(13)(i).The insertion of the “same drug” concept into the exclusivity regulations effectively limits the scope of exclusivity protection......
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Braeburn Inc. v. U.S. Food & Drug Admin., Civil Action No. 19-982 (BAH)
...same drug, the FDA might determine that Brixadi Monthly is clinically superior to Sublocade and thus not subject to Sublocade's ODE. 21 C.F.R. §§ 316.3(b)(14), 316.31(a). Again, resolution of these issues is not necessary here, but merely recognizing them as possibilities adds layers of dou......
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14 cases
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Eagle Pharm., Inc. v. Azar, No. 18-5207
...as a previously approved drug if it shares the same "active moiety"—the same active ingredient—and "is intended for the same use," 21 C.F.R. § 316.3(b)(14)(i). The FDA has also determined, however, that, "if the subsequent drug can be shown to be clinically superior to the first drug"—despi......
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Depomed, Inc. v. U.S. Dep't of Health & Human Servs., Civil Action No. 12–cv–1592 KBJ
...“that if the subsequent drug can be shown to be clinically superior to the first drug, it will not be considered to be the same drug.” 21 C.F.R. § 316.3(b)(13)(i).The insertion of the “same drug” concept into the exclusivity regulations effectively limits the scope of exclusivity protection......
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Braeburn Inc. v. U.S. Food & Drug Admin., Civil Action No. 19-982 (BAH)
...same drug, the FDA might determine that Brixadi Monthly is clinically superior to Sublocade and thus not subject to Sublocade's ODE. 21 C.F.R. §§ 316.3(b)(14), 316.31(a). Again, resolution of these issues is not necessary here, but merely recognizing them as possibilities adds layers of dou......
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Baker Norton Pharm. v. U.S. Food & Drug Admin., No. CIV. A. 98-927 SSH.
...the FDA promulgated its final orphan drug regulations on how to implement the orphan drug exclusivity right. One of the regulations, 21 C.F.R. § 316.3(b)(13)(i), provided a definition for determining when two drugs are the "same drug" and thus the second drug may not be approved for market ......
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10 firm's commentaries
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Bipartisan Congress Intensifies Efforts to Restrict Orphan Drug Exclusivity
...Notably, the term “active moieties” is associated with small-molecule drugs, not typically with larger molecules such as biologics. See 21 C.F.R. § 316.3 (14)(i), In contrast, the Senate bill requires this information for all drugs that “are covered by the same designation” as the § (a)(2)(......
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Be Careful to Not Beat Yourself in the Race To Market and Wind Up Excluding Your Own Ingredient From Being Allowed in Food or Dietary Supplements
...“article” to mean either the entire product or a component of the product; • the term “active moiety” to follow the definition under 21 C.F.R. § 316.3(b)(2); • the term “authorized for investigation” to mean that the article is the subject of an IND that has gone into effect as described in......
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Bipartisan Congress Intensifies Efforts To Restrict Orphan Drug Exclusivity
...Notably, the term "active moieties" is associated with small-molecule drugs, not typically with larger molecules such as biologics. See 21 C.F.R. § 316.3 (14)(i), In contrast, the Senate bill requires this information for all drugs that "are covered by the same designation" as the § (a)(2)(......
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Orphan Drug Act Reform: Will the Loophole be Closed During the Biden Administration?
...and Impact, OEI-09-00-00380 (2001). 6 See 21 U.S.C. § 360cc(a). 7 See id. § 360bb(a)(2). 8 See id. § 526(a)(2)(B); see also 21 C.F.R. § 316. 9 See H.R. REP. No. 116-572, at 3-5 10 Id. 11 See Letter from U.S. Dept. of Health & Human Servs. To Charles O’Keeffe, Exec. Vice Pres., Reckitt & Col......
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1 books & journal articles
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The Statutory and Regulatory Scheme
...sponsor must submit its application (or supplement) for pediatric exclusivity 15 months prior to expiration of adult exclusivity. 55. 21 C.F.R. § 316.3(b)(13)(ii). 56. 21 C.F.R. § 316.3(b)(3). 57. 21 U.S.C. § 355a. 58. 21 U.S.C. § 355a(c). 59. Regarding “off-label” uses, it has been notably......