Romanette ii confers an exclusivity period of five years, during which “no [abbreviated] application which refers to the [first-in-time] drug” may be approved. 21 U.S.C. § 355(c)(3)(E)(ii). FDA regulations interpret exclusivity under romanette ii to block any abbreviated application for a drug whose active moiety is the same as the New Chemical Entity. 21 C.F.R. § 314.108(a).

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Romanette iii confers three years of exclusivity and bars approval of abbreviated applications for the same “conditions of approval of such drug in the [first-in-time] application.” hierarchical headings Consider tiered numbers. Tra­di­tion­ally, hi­er­ar­chi­cal head­ings in le­gal doc­u­ments start with ro­man nu­mer­als at the top level (I, II, III); then switch to cap­i­tal let­ters (A, B, C); then nu­mer­als (1, 2, 3); then low­er­case let­ters (a, b, c); then ro­manettes (i, ii, iii); and then vari­a­tions of the above us­ing two paren­the 2020-09-24 · Roma II beans are typically ready for harvest in 59 days, while Romanette beans are ready in 55 days. Look for beans that are broad, fleshy and green with well-developed beans inside. What does romanette mean?

Romanette ii

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romanette ( English) ( colloquial, legal, typography, US) A Roman numeral in lower case, such as “ii”, as frequently introduces list items; page 3.14: " […] (romanette (ii) in the Columbia/HCA Healthcare Corporation waiver-of-liability provision included in us-patent: " This can best be Romanette ii confers an exclusivity period of five years, during which “no [abbreviated] application which refers to the [first-in-time] drug” may be approved. 21 U.S.C. § 355(c)(3)(E)(ii). FDA regulations interpret exclusivity under romanette ii to block any abbreviated application for a drug whose active moiety is the same as the New romanette (plural romanettes) (colloquial, law, typography, US) A Roman numeral in lower case, such as “ii”, as frequently introduces list items; or, a list item introduced by such. quotations The court held that romanette (ii) of the statute in issue did not limit eligibility for legal relief. in Romanette (i) and (ii) up to the break with "committed by." So that it is an offense that is a misdemeanor and has as an element "committed by." You know, these -- these two different clauses both modify "offense," just as a grammatical matter, not looking at this Romanette (i) and (ii), but just looking at that 8 Alderson Reporting Company romanette (ii) incorporating the conservation of deaths principle be added. 2.

in Romanette (i) and (ii) up to the break with "committed by." So that it is an offense that is a misdemeanor and has as an element "committed by." You know, these -- these two different clauses both modify "offense," just as a grammatical matter, not looking at this Romanette (i) and (ii), but just looking at that 8 Alderson Reporting Company

Romanette ii confers five years of market exclusivity during which “no [abbreviated] application which refers to the [first-in-time] drug” may be approved. See 21 CFR § 314.3 (b).

Romanette ii

27 Mar 2019 5lA-4.116, and 5lA-4.125; adding a new Division 51-4.900 and a new Division 51A-4.1100; providing mixed-income development bonuses for 

953 likes · 6 talking about this · 211 were here. Dans un cadre chaleureux et familial, la Romanette vous accueille dans l’un des plus beaux villages de Wallonie, Torgny. (II) Parking island landscape areas are not required adjacent to handicapped parking spaces. (cc) Except as provided in this romanette, maximum number of parking spaces allowed between parking island landscape areas is 12. Word replaces the integer numbers with Roman numerals as pages i, ii and iii.

A Roman numeral in lower case, such as “ii”, as frequently introduces list items; or, a list item introduced by such.
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Since SR-FICC-2018-007 removed references to EPN Procedures, there is currently a stray romanette (ii). FICC is proposing to delete romanette (iii) in the first sentence in Section 5 of Rule 1 of Article III of the EPN Rules, renumber current romanette (iv) to (iii) and revise the subsequent references from items (iii) and (iv) to items (ii Romanetta II.. Kdo napsal knihu Romanetta II.? Autorem je Jakub Arbes. Hodnocení, recenze, zajímavosti a informace o knize. ČBDB.cz - Databáze knih.
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29 Aug 2017 Romanette ii, the FDCA's broadest grant of marketing exclusivity, applies to what FDA regulations refer to as “New. Chemical Entities”: drugs for 

ČBDB.cz - Databáze knih. Romanette (i) alone suffices. Romanette (ii) alone suffices, providing the contribution meets the threshold for authorship. Romanette (iii) Romanette (iv) by itself does not suffice, and thus would have to be combined with one of the other sufficient conditions above. Roberts stopped Assistant to the Solicitor General Nicole Saharsky during a U.S. Supreme Court oral argument last month when she referred to “romanette (i) and (ii),” reports The BLT: The Blog 148.5k Followers, 2,853 Following, 848 Posts - See Instagram photos and videos from 🎀Romanette🎀official (@romaanettee) The Exchange also proposes to amend romanette (ii) across all Tapes in order to include NOM Market Maker volume as part of the qualifyin g volume and to reduce the volume threshold in Penny Pilot and Non- Penny Pilot Options from 1.25% to 0.90%.

5 May 2020 II. Clearing Agency's Statement of the Purpose of, and Statutory Basis to delete the description contained in romanette (ii) in the definition of 

2015-10-20 · Nearly every legal document can benefit from clear, consistent headings. Here in part 2, I offer recommendations for making headings consistent, commend some traditional outlining rules, and suggest a simple numbering system. Romanette II, referral of certain aliens, it says if the asylum officer determines at the time of the interview that the alien has a credible fear of persecution, the alien shall be detained for further consideration of the application for asylum. And so, in the very provision in which.

Word replaces the integer numbers with Roman numerals as pages i, ii and iii. See the following image: 3. Now, place cursor at the Footer section of the fourth page. Then, on the Insert tab, within the group Header & Footer, click the Page Number drop-down and then click Current Position drop-down list and select Plain Number format. 2020-05-05 · (ii) Proposal To Delete References to Services and Service-Related Provisions That Are No Longer Provided and/or Active in the GSD Rules and the MBSD Rules A. GSD Rules (1) Freddie Mac Auctions The GSD Rules contain provisions related to Auction Purchases of Eligible Freddie Mac Securities, which is a service that was not utilized 7 and which FICC does not expect to be utilized. 11 Nov 2008 In discussing the statute at issue, 18 U.S.C. 922 (a)(33)(A)(i) and (ii), She called them "Romanette one and two," using an obscure but  17 Dec 2013 The Second Circuit disagreed, holding that the “(i)” wasn't a lowercase Roman numeral (“romanette”) but instead represented the lowercase  ร่วมเป็นสักขีพยานในการทำลายสถิติความเร็วทางบกด้วยอุปกรณ์จับเวลา Chronocinégines ที่บริษัทผลิตขึ้นในปี 1954 ในครั้งนั้น นักขับ Donald Campbell พร้อม รถ Bluebird II  romanetteの意味や使い方 語源Roman (numeral) +‎ -ette (“a diminutive”) The court held that romanette (ii) of the statute in issue did not limit eligibility for legal   epoxy black satin brass shade alabaster ø 150 mm weight.