Submission of NDA definition

Submission of NDA means the submission by the Company and acceptance by the U.S. Food and Drug Administration of a new drug application (“NDA”) with relating to a pharmaceutical for the treatment of Friedreichs Ataxia or related neurodegenerative or neuromuscular diseases.
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Examples of Submission of NDA in a sentence

  • Please refer to the draft guidance for industry Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions (February 2018) and the associated Bioresearch Monitoring Technical Conformance Guide Containing Technical Specifications.9 ONCOLOGY PILOT PROJECTS The FDA Oncology Center of Excellence (OCE) is conducting two pilot projects, the Real-Time Oncology Review (RTOR) and the Assessment Aid.

  • Please refer to the draft guidance for industry Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions (February 2018) and the associated Bioresearch Monitoring Technical Conformance Guide Containing Technical Specifications.7 ONCOLOGY PILOT PROJECTS The FDA Oncology Center of Excellence (OCE) is conducting two pilot projects, the Real-Time Oncology Review (RTOR) and the Assessment Aid.

  • Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions.

  • In addition to the referenced FDA Guidance for Industry, entitled “Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions,” also refer to the FDA Technical Specifications Document, entitled “Bioresearch Monitoring Technical Conformance Guide,” available at: https://www.fda.gov/media/85061/download.

  • First of all, it has proven to be extremely difficult to develop an effective chain-of-custody control that tracks wood products from the forest through to finished products.

  • Please refer to the draft guidance for industry Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions (February 2018) and the associated Bioresearch Monitoring Technical Conformance Guide Containing Technical Specifications.13 ONCOLOGY PILOT PROJECTS The FDA Oncology Center of Excellence (OCE) is conducting two pilot projects, the Real-Time Oncology Review (RTOR) and the Assessment Aid.

  • BackgroundFDA is announcing the availability of: (1) a draft guidance for industry entitled “Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions ” and (2) the BIMO Technical Conformance Guide.

  • The Chair of the RDA Board is an ex officio non-voting member of RSC.

  • For all other entities, the guidance in this Subtopic will be effective as of the beginning of fiscal years, and interim periods within those years, beginning on or after December 15, 2009.

  • Our commercial product sales were up 45.5% for the fourth quarter on a year-over-year comparison, while the commercial market was only up in the mid-single digits basis.

Related to Submission of NDA

  • Bid Submission Requirement means a task a Prospective Contractor must complete when submitting a bid response. These requirements will be distinguished by using the term “shall” or “must” in the requirement.

  • Non-Acceptance of Proposal means another proposal was deemed more advantageous to the University or that all proposals were rejected.

  • the decisions means the decisions of the CMA on the questions which it is required to answer by virtue of section 35 of the Act;

  • Notification of Claim means the process of intimating a claim to the insurer or TPA through any of the recognized modes of communication.

  • Submission Location means the submission location identified as such in the Summary of Key Information.

  • CEC Certification and Verification means that the CEC has certified (or, with respect to periods before the Project has commenced commercial operation (as such term is defined by and according to the CEC), that the CEC has pre-certified) that the Project is an ERR for purposes of the California Renewables Portfolio Standard and that all Energy produced by the Project qualifies as generation from an ERR for purposes of the Project.

  • Medicaid Notification of Termination Requirements Any Contractor accessing payments for services under the Global Commitment to Health Waiver and Medicaid programs who terminates their practice will follow the Department of Vermont Health Access, Managed Care Organization enrollee notification requirements.

  • CPUC Decisions means CPUC Decisions 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000 and any other existing or subsequent decisions, resolutions or rulings related to resource adequacy, as may be amended from time to time by the CPUC.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • major non-compliance outcome notification means a notification received by a council under section 19N(3) or (4) of the Food Act 1984, or advice given to council by an authorized officer under that Act, of a deficiency that does not pose an immediate serious threat to public health but may do so if no remedial action is taken

  • Request for Applications (RFA) means the document (including all amendments and attachments) issued by the System Agency under which applications for Program funds were requested, which is incorporated by reference for all purposes in its entirety.

  • Tax Certification Forms means any forms or other documentation as may be issued or required by a Tax Authority or by us from time to time to confirm your tax status [or the tax status of a Connected Person].

  • Selected submission means and refers to the submission sent to the City of Waco by the Selected Firm.

  • Service Authorization Request means a Provider’s or Enrollee’s request to the Contractor for the provision of a service.

  • CE marking of conformity or ‘CE marking’ means a marking by which the manufacturer indicates that the device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;

  • Promotion of Access to Information Act ’ means the Promotion of Access to Information Act, 2000 (Act No. 2 of 2000);

  • NZOC Nomination and Selection Regulation means the regulation of NZOC relation to the nomination and selection Process for all Olympic and Commonwealth games, including the Games.

  • Written application or "written election" means a written instrument, required by statute or the

  • WTO GPA country construction material means a construction material that—

  • Bid Submission Date means the last date by which the City will accept Bids for an Invitation For Bid.

  • Third Party Applications means online, Web-based applications and offline software products that are provided by third parties and are identified as third-party applications, including but not limited to those listed on the AppExchange and the Reseller Application.

  • StarCompliance Code of Ethics application means the web-based application used to electronically pre-clear personal securities transactions and file many of the reports required herein. The application can be accessed via the AB network at: https://alliance-ng.starcompliance.com/.

  • Locational Deliverability Area Reliability Requirement means the projected internal capacity in the Locational Deliverability Area plus the Capacity Emergency Transfer Objective for the Delivery Year, as determined by the Office of the Interconnection in connection with preparation of the Regional Transmission Expansion Plan, less the minimum internal resources required for all FRR Entities in such Locational Deliverability Area.

  • Certificate of noncompliance means a document known as a certificate of noncompliance which is provided by the centralized collection unit of the department of revenue certifying that the named applicant or licensee has an outstanding liability placed with the unit and has not entered into an approved payment plan to pay the liability.

  • Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.