Original NDA definition

Original NDA means the original New Drug Application filed with the FDA for the product incorporating API from a source other than Equateq.
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Original NDA means a complete new NDA that has never before been submitted to the FDA.
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Original NDA shall have the meaning set forth in Section 3.1(b).
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Examples of Original NDA in a sentence

  • The declara- tions required by this section must be signed by the applicant or patent owner, or the applicant’s or patent owner’s attorney, agent (representa- tive), or other authorized official.(d) When and here to submit patent information—(1) Original NDA.

  • The declara- tions required by this section must be signed by the applicant or patent owner, or the applicant’s or patent owner’s attorney, agent (representa- tive), or other authorized official.(d) When and where to submit patent information—(1) Original NDA.

  • Source: Original NDA submission This reviewer again referred to the recent NDA submissions for the aripiprazole and risperidone adolescent schizophrenia programs to compare placebo response between the Russian sites in HGIN compared to the aripiprazole and risperidone pivotal schizophrenia trials.

  • Except as amended hereby, the Original NDA remains in full force and effect in accordance with its terms, and each party hereto confirms its obligations thereunder.

  • A.R. 708.D. In 2010, The FDA Approved Questcor’s Efficacy Supplement Application to Add Infantile Spasms to Acthar’s Label and Directed Questcor to Stop Using NDA Number 022432 in Favor of Acthar’s Original NDA Number 008372 In 2010, the FDA approved Questcor’s efficacy supplement application to add infantile spasms to Acthar’s label indications.

  • Original NDA: CMS had proposed to use “original NDA” to define an NDA as equivalent to an NDA filed by the manufacturer for approval under section 505 of the FFDCA for purposes of approval by FDA for safety and effectiveness.

  • As set forth in the chart below, the average time for FDA approval of these therapies was 221.6 days: Original NDA and Original BLA Approvals Filed By Bristol Myers and Celgene, 2014-2020 Shortest Days to Approval D.

  • Abbott shall prepare and provide to CTI for FDA submission the Original IND and Original NDA annual reports, to the extent applicable, and Periodic Report for the period of time during which the Original IND and Original NDA were owned by Abbott.

  • Jessup, Review and Evaluation of Pharmacology Toxicology Data: Original NDA Review (1996) (“the 1996 FDA SBOA”, Ex. 1007A).Public accessibility is based on the “facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Lister, 583 F.3d 1307, 1311 (Fed.

  • In a submission dated June 28, 2017, the applicant submitted an Original NDA, combination therapy of Tezacaftor/Ivacaftor for the proposed indication of Cystic Fibrosis (CF).


More Definitions of Original NDA

Original NDA means the original New Drug Application filed with the FDA for the product incorporating API from a source other than Equateq. “Party” and “Parties” have the meanings given such terms, respectively, in the preamble of this Agreement.
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Related to Original NDA

  • Original RRA shall have the meaning given in the Recitals hereto.

  • Original Note shall have the meaning assigned to such term in the recitals.

  • Original Agreement has the meaning set forth in the recitals.

  • Original Plan means any defined contribution plan which meets the requirements of Code Section 401 and referred to in Article XII of the Plan.

  • Original LLC Agreement has the meaning set forth in the recitals to this Agreement.

  • Original Notes means the Initial Notes and any Exchange Notes issued in exchange therefor.

  • Existing Agreement has the meaning set forth in the recitals hereto.

  • Original Material means a material provided by one of the Parties and used in the Research Project.

  • Original Facility Agreement means the facility agreement dated 19 December 2018 and made between, amongst others, (i) the Borrower, (ii) the Lenders, (iii) the Mandated Lead Arrangers, (iv) the Facility Agent and the SACE Agent and (v) the Security Trustee.

  • Original Loan Agreement has the meaning set forth in the Recitals to this Agreement.

  • Original manufacturer means the original component manufacturer, the original equipment manufacturer, or the contract manufacturer.

  • Original Effective Date means the Effective Date under, and as defined in, the Original Credit Agreement.

  • Original package means the unbroken container or wrapping in which any drug or medicine is

  • Manufacturing Agreement has the meaning set forth in Section 2.6.

  • Substitution Agreement means the substitution agreement, substantially in the form set forth in the Schedules as entered into/ proposed to be entered into between the Authority, Developer, and the Lenders in relation to the substitution of the Developer with the Nominated Company in accordance with the Agreement;

  • Original Financing Agreement means the development credit agreement for a Social Investment Program Project between the Recipient and the Association, dated April 7, 2003, as amended to the date of this Agreement (Credit No. 3740-BD).

  • Original Project means the Project described in the Original Financing Agreement.

  • Existing Registration Rights Agreement shall have the meaning given in the Recitals hereto.

  • Existing Products Tangible Products and intangible licensed Products which exist prior to the commencement of work under the Contract. Contractor retains the burden of proving that a particular product was existing before commencement of the Project. .

  • Replacement Agreement means an agreement entered into as a replacement for any Relevant Agreement;

  • Amended and Restated Registration Rights Agreement has the meaning set forth in the Recitals.

  • Amending Agreement means the Agreement of which a copy is set out in the Third Schedule to the Iron Ore (Hamersley Range) Agreement Xxx 0000 (which Agreement was approved by the Iron Ore (Hamersley Range) Agreement Act Amendment Act 1968);

  • Initial Agreement has the meaning set forth in the recitals to this Agreement.

  • Existing Agreements has the meaning as set forth in Section 3.2 hereof.

  • Original Rights shall have the meaning set forth in Section 1(f)(i) hereof.

  • Existing Plan means the Amended and Restated Novatel Wireless, Inc. 2000 Stock Incentive Plan.