Drug Master Files definition

Drug Master Files means the information submitted to the FDA as described in 21

Drug Master Files means the information submitted to the FDA as described in 21 C.F.R. Part 314.420 related to a Product.

Drug Master Files or "DMFs" means reference files submitted to FDA that are used in the review of investigational and marketing applications for human agents. Drug Master Files allow another party to reference this material without disclosing to that party the contents of the file.

Examples of Drug Master Files in a sentence

• Licensee shall make certain data generated during the research and development of Testim accessible to Licensor through the preparation and filing of one or more Drug Master Files (“DMF”).

• Except as otherwise provided herein, nothing in this Agreement shall, during or after the Term hereof, give Reliant any of Novartis’ rights in or to the Product, including, but not limited to, Novartis’ rights in or to trademarks, copyrights, the NDAs, ANDAs, Drug Master Files, patent rights, preclinical or clinical data, manufacturing rights relating to the Product, or any supply of the Product or the active ingredient thereof.

• Apicore manufactures over 100 different API’s, including over 35 for which Drug Master Files have been submitted to the FDA and 12 that are approved for commercial sale in the U.S. by Apicore’s customers.

• Catalent expressly agrees that Xencor shall have the right to reference any and all Drug Master Files relating to any Product or Technology covered by this Agreement insofar as such information is necessary or desirable in the prosecution of any submission to the FDA and/or other regulatory agencies.

• In addition, Catalent will maintain at Catalent’s expense, the relevant Drug Master File, including any updates thereto, and shall provide a letter authorizing Client to reference Catalent Drug Master Files on file with the FDA and other regulatory authorities in connection with the pursuit of Regulatory Approval for the Product.

More Definitions of Drug Master Files

Drug Master Files means all Regulatory Files with respect to the manufacture or design of a Product, including without limitation drug master files, design history files and similar files.

Drug Master Files means all drug master files that are referred to or referenced in New Drug Application No. 20122-001, and owned or controlled by or in the possession of Pfizer.

Drug Master Files means the information required by the FDA as described in 21 C.F.R. Part 314.420 related to Propofol.

Drug Master Files. DMFs”) means reference files submitted to the FDA that are used in the review of investigational and marketing applications for human drugs. Drug Master Files are submitted to the FDA to allow another party to reference this material without disclosing to that party the contents of the file.

Drug Master Files means Type IV Drug Master Files (as that term is used in 21 CFR 314.420(a)(4)), including all cover letters and amendments.

Drug Master Files means the information submitted to the FDA as described in 21 C.F.R. Part 314.420 relating to any Product included in this Order.

Drug Master Files means all drug master files referred to or referenced in the NDA owned or controlled by or in the possession of X-X.