Drug Approval definition

Drug Approval means an approval granted by the appropriate Regulatory Authority to market the Product in the Field in any particular jurisdiction in the Licensed Territory.

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Drug Approval means an approval of a BLA, NDA, or of a MAA, or any corresponding Regulatory Approval for the Commercialization of a pharmaceutical product for a particular indication in any other country or region of the world, including other than the U.S. and the EU /European Economic Area.

Drug Approval means an approval, authorization or license (including, without limitation, an Investigational New Drug Application (“IND”) authorizing human testing of a drug, New Drug Application, conditional Marketing Authorization Application and Marketing Authorization Application) granted by a Governmental Authorities (including, without limitation, the FDA and the European Commission) to permit the use in human use, sale and marketing of a Product.

Examples of Drug Approval in a sentence

The Party that has filed the Drug Approval Application in such country within the Territory or, if no Drug Approval Application has been filed, the Party which has filed the IND (or foreign equivalent) in such country within the Territory shall provide an appropriate response to such contact after such consultation with the other Party.
The purpose of such foregoing interactions shall be to identify and resolve any potential reasonable concerns of Ardelyx in advance of the proposed filing of such Drug Approval Applications (and in particular the initial Drug Approval Application) in the U.S. Territory.
In addition, ▇▇▇▇▇▇ shall provide Enanta with initial IND filings or Drug Approval Applications sufficiently in advance of submission so that Enanta may review and comment on the substance of such Regulatory Filing or other document or correspondence.
Such reports shall summarize GENENTECH’s material efforts to Develop and commercialize all Licensed Products hereunder, identify the Drug Approval Applications with respect to any Licensed Product that GENENTECH and its Sublicensees have filed, sought or obtained in the prior twelve (12)-month period, and any they reasonably expect to make, seek or attempt to obtain in the following twelve (12)-month period.
Subject to the Retained Rights, Mereo shall have the sole right to prepare, obtain and maintain Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions (including INDs) and to conduct communications with the Regulatory Authorities, for Products in the Field in the Territory in its name.
Novartis shall have the sole right to select Licensed Compounds for development into Licensed Products, to discontinue development of Licensed Products, to substitute new or back-up Licensed Products for discontinued ones, to control the Development thereof, and to hold all Drug Approval Applications and obtain and hold all Regulatory Approvals with respect thereto on a worldwide basis, subject to the obligations of diligence set forth in this Section 3.
BMS shall prepare and draft all filings (including any supplements or modifications thereto and including the preparation of any electronic submission of a Drug Approval Application) to Regulatory Authorities in each such country for such Product.
Without limiting the generality of the foregoing, Novartis shall have full control and authority and sole responsibility for (A) making all Regulatory Filings for Licensed Products and filing all Drug Approval Applications and otherwise seeking all Regulatory Approvals regarding such matters and (B) reporting of all Adverse Events to Regulatory Authorities if and to the extent required by Applicable Laws.
The Lead Regulatory Party shall reasonably attempt to include the other Party in any unscheduled, ad-hoc meetings, conferences and discussions with the Regulatory Authority concerning any pending IND, Drug Approval Application or any material regulatory matters relating to a Collaboration Product, and will promptly copy such other Party on a contact report.
With respect to each Included Target, from and after the Inclusion Date for such Included Target, AbbVie shall, as between the Parties, have the sole right to prepare, obtain and maintain Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions and to conduct communications with the Regulatory Authorities in the Territory for the Licensed Products that contain a Licensed Compound Directed to such Included Target.

More Definitions of Drug Approval

Drug Approval means the regulatory approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction, including, for purposes of Regulatory Approval in the US, a New Drug or a Biological License and all supplements filed pursuant to the requirements of the FDA (including all documents, data and other information concerning a Product that are necessary for, or included in, FDA approval to market a Product) and, for purposes of Regulatory Approval in the EU, all and any regulatory approval by the EMEA or any other applicable national regulatory authority.

Drug Approval shall have the meaning ascribed to it in the Mundipharma Collaboration Agreement.

Drug Approval means approval of an application for the Regulatory Approval required before commercial sale or use of a Product in a regulatory jurisdiction, including with respect to the U.S. a new drug application (“NDA”), a supplemental new drug application, a prior approval supplement to an NDA, a Pre-market Approval Application, clearance of a Pre-market Notification Submission (510(k)), as applicable, or any amendments thereto submitted to the FDA, and with respect to the EMEA or countries outside the U.S. any foreign equivalents thereof.

Drug Approval is defined in Section 5.14.

Drug Approval. APPLICATION shall mean an application for Marketing Authorization required to be approved before commercial sale or use of a Product as a drug in a country of the Territory.

Drug Approval means an approval granted by the appropriate Government Entity to market the Product in the Novated Territory.