Regulatory Filing definition

Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.
Regulatory Filing means any documentation constituting or relating to or supporting any filing or application with any Governmental Authority with respect to a Product, including any documents submitted to any Governmental Authority, including INDs, applications for Regulatory Approval, and all correspondence with any Governmental Authority with respect to any Product (including minutes of any meetings, telephone conferences or discussions with any Governmental Authority).
Regulatory Filing means all applications, filings, submissions, approvals, licenses, registrations, permits, notifications and authorizations (or waivers) with respect to the testing, Development, manufacture or Commercialization of any Licensed Compound or Product made to or received from any Regulatory Authority in a given country, including any INDs and XXXx.

Examples of Regulatory Filing in a sentence

  • In the event of failure to assign such Regulatory Filings to Celgene, Bluebird hereby consents and grants to Celgene the right to access and reference (without any further action required on the part of Bluebird, whose authorization to file this consent with any Regulatory Authority is hereby granted) any such Regulatory Filing.

  • Applications MUST be date and time stamped by the Commission’s Electronic Regulatory Filing (ERF) system on or before the date and time that the application is due.

  • Appendix B to NDA Regulatory Filing Review Questions for 505(b)(2) Applications 1.

  • Term, Termination, and Regulatory Filing -- This Agreement becomes effective and continues in effect until .

  • Promptly following the submission of each Regulatory Filing, and any amendments or supplements thereto, the Party making such submission shall provide a full and complete copy of such filing to the other Party for purposes of determining whether the submitting Party has Materially Used the other Party’s Shared Clinical Trial Data without having paid its applicable Shared Clinical Trial Cost Sharing Percentage associated with such Shared Clinical Trial Data.


More Definitions of Regulatory Filing

Regulatory Filing means any filing with a Regulatory Agency relating to or to permit or request, as applicable, the clinical evaluation or Registration of a Licensed Product. Regulatory Filings include without limitation INDs and NDAs.
Regulatory Filing means an NDA, IND, or any foreign counterparts thereof, and any other filings required by regulatory authorities relating to the Development, manufacture, or Commercialization of any Licensed Product.
Regulatory Filing means any New Drug Application or Abbreviated New Drug Application, or any other application, notification or submission made to or with the FDA or other regulatory authority for Registration of a human pharmaceutical product, together with all amendments and supplements to any of the foregoing.
Regulatory Filing means any filing or application with any Regulatory Authority, including INDs and XXXx and authorizations, approvals or clearances arising from the foregoing, including Marketing Approvals, and all correspondence with the FDA or other relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the FDA or other relevant Regulatory Authority, in each case with respect to a Licensed Product.
Regulatory Filing means any submission to a Regulatory Authority, including all applications, registrations, licenses, authorizations and approvals (including Regulatory Approvals), together with any related correspondence and documentation submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents and all clinical studies and tests, relating to a product and all data contained in any of the foregoing, including all INDs, Drug Approval Applications, regulatory drug lists, advertising and promotion documents, Clinical Data, adverse event files and complaint files, and include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.
Regulatory Filing means all applications, filings, submissions, approvals, licenses, registrations, permits, notifications, and authorizations (or waivers) with respect to the testing, Development, manufacture, or Commercialization of any Product made to or received from any Regulatory Authority in a given country, including any INDs and MAAs.
Regulatory Filing means, with respect to the United States, an NDA, BLA, or IND, any foreign counterparts or equivalents of any of the foregoing, any DMFs, and any other filings or submissions required by or provided to Regulatory Authorities relating to the manufacture, Development or Commercialization of any Product, including any supporting documentation, data, correspondence, meeting minutes, amendments, supplements, registrations, licenses, regulatory drug lists, advertising and promotion documents, adverse event files, complaint files, and manufacturing, shipping, or storage records with respect to any of the foregoing.