Initial NDA definition

Initial NDA means the NDA filed by Novartis on or about 19 January 1960 for the following indications: initial milk let-down, milk retention, incipient mastitis, impaired milk let-down.
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Initial NDA means the New Drug Application and all amendments and supplements thereto filed with the FDA relating to the Patents or for which the Know-How is being used.
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Initial NDA means, where appropriate, either (i) the MAA, or (ii) the New Drug Application (#*****) submitted by Pharmos to the United States Food and Drug Agency on March 30, 1995, including in either case any amendments, supplements, schedules and exhibits thereto.
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Examples of Initial NDA in a sentence

  • Otherwise Buyer has to arrange finder fee for his Broker/agent out of theirBuyer's Initial NDA TO SIGN BY BUYER FOR BUSINESS/PROPERTY INQUIRED pocket.

  • CPDLC Transfer Using FAN and FCN Messaging – Initial NDA not Delivered 58Figure 7-5.

  • The Sponsor had already completed study enrollment to fulfill a PIP agreement with EU at the time of the WR was issued.• February 2016: Revised WR to extend deadline for submitting study reports to FDA.• March 2016: FDA granted orphan-drug designation of ivabradine for treatment of pediatric patients with DCM• December 2016: Initial NDA 209664 submission.

  • Still, the response rate was just over 50 % from contacts primarily found through private channels.

  • CPDLC Transfer Using FAN and FCN Messaging – Initial NDA notDelivered 62Figure 7-5.

  • The Sponsor had already completed study enrollment to fulfill a PIP agreement with EU at the time of the WR was issued.‌‌‌• February 2016: Revised WR to extend deadline for submitting study reports to FDA.• March 2016: FDA granted orphan-drug designation of ivabradine for treatment of pediatric patients with DCM‌• December 2016: Initial NDA 209664 submission.

  • All other terms were incorporated from the Contract.”).) Nowhere does Plaintiff allege that any of these supposed oral modifications included making Mr. Barkatullah a contracting party to the Contract or the Initial NDA, and the court accordingly need not assume that Plaintiff can prove such facts.

  • Ex. B at 3), and the Initial NDA states that it “shall not be modified, amended or altered except by an instrument in writing signed by both of the parties hereto” (id.

  • As is plain on the face of the Initial NDA, those parties only include Plaintiff and Defendant Barkatech, not Mr. Barkatullah.Likewise, the Contract states that that agreement “is made between VideoEFX Corporation .

  • Plaintiff points to the Initial NDA and Contract as the basis for its claims against Mr. Barkatullah.


More Definitions of Initial NDA

Initial NDA the NDA filed by the Licensor under the terms of Clause 5 for the Product in the Territory.
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Initial NDA. The term ‘Initial NDA’ means New Drug Application No. 021-892 as filed with the United States Food and Drug Administration.
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Initial NDA means the NDA submitted to the FDA on February 15, 2022 by Forma for the Licensed Product in the Initial Indication with the identifier NDA 215814 and all Regulatory Filings submitted to the FDA by Forma in connection with such NDA, including any responses to complete response letters and any refiling, reapplication, additional filing or additional application.
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Initial NDA means the NDA (#******) [Confidential Information omitted and filed separately with the SEC] submitted by Pharmos to the FDA on March 30, 1995, including any amendments, supplements, schedules and exhibits thereto.
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Related to Initial NDA

  • Initial Negotiation End Date has the meaning set forth in Section 12.2(a).

  • Initial Indication means the treatment of Netherton Syndrome in humans in the Territory.

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • Initial Notes has the meaning set forth in the recitals hereto.

  • Initial Note means each initial Governmental Lender Note registered by the Comptroller and subsequently canceled and replaced by a definitive Governmental Lender Note pursuant to this Funding Loan Agreement.

  • Initial Notice shall have the meaning set forth in Section 7.1.

  • Additional Indication means any indication other than the Initial Indication.

  • Initial Filing Date means the date on which the Initial Registration Statement is filed with the SEC.

  • Initial application means the Application first provided to MFA on or before an Application Deadline to request an allocation of Tax Credits.

  • Initial Registration Statement means the initial Registration Statement filed pursuant to this Agreement.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Registration Filing Date means the date that is 60 days after date of the final closing of the PPO.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • IND means (i) an investigational new drug application filed with the FDA for authorization to commence clinical studies and its equivalent in other countries or regulatory jurisdictions and (ii) all supplements and amendments that may be filed with respect to the foregoing.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Additional Filing Date means the date on which the Additional Registration Statement is filed with the SEC.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Additional Notes means additional Notes (other than the Initial Notes) issued under this Indenture in accordance with Sections 2.02 and 4.09 hereof, as part of the same series as the Initial Notes.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Required Filing Date has the meaning set forth in Section 3.1.

  • Original Registration Statement. As used in this Agreement, the terms “amendment” or “supplement” when applied to the Registration Statement or the Prospectus shall be deemed to include the filing by the Company with the Commission of any document under the Exchange Act after the date hereof that is or is deemed to be incorporated therein by reference. All references in this Agreement to financial statements and schedules and other information which is “contained,” “included” or “stated” in the Registration Statement or the Prospectus (and all other references of like import) shall be deemed to mean and include all such financial statements and schedules and other information which is or is deemed to be incorporated by reference in or otherwise deemed under the Securities Act to be a part of or included in the Registration Statement or the Prospectus, as the case may be, as of any specified date; and all references in this Agreement to amendments or supplements to the Registration Statement or the Prospectus shall be deemed to mean and include, without limitation, the filing of any document under the Exchange Act which is or is deemed to be incorporated by reference in or otherwise deemed under the Securities Act to be a part of or included in the Registration Statement or the Prospectus, as the case may be, as of any specified date. At the time the Registration Statement was or will be originally declared effective and at the time the Company’s most recent annual report on Form 10-K was filed with the Commission, if later, the Company met the then-applicable requirements for use of Form S-3 under the Securities Act. During the Agency Period, each time the Company files an annual report on Form 10-K the Company will meet the then-applicable requirements for use of Form S-3 under the Securities Act.

  • Initial Filing Deadline means the date which is thirty (30) calendar days after the Closing Date.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.