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”).

• 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.

• 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.

• The CMC Section of any regulatory filing, to the extent it relates to the System, may be maintained by ALZA, in one or more of ALZA's Drug Master Files to the extent permissible under applicable laws and regulations, for which Durect shall have the right of reference for each Product hereunder.

• CAMBREX shall provide, or cooperate with RAPTOR to provide, the appropriate authorizations to each applicable Regulatory Authority allowing RAPTOR (and/or its designee) the right to reference all Drug Master Files to support any regulatory filing for any Product developed, manufactured and/or commercialized by RAPTOR, its Affiliates and/or licensees.

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 means Type IV Drug Master Files (as that term is used in 21 CFR 314.420(a)(4)), including all cover letters and amendments. “EC Commitments” means the commitments submitted by Dirac and Descartes pursuant to Article 8(2) of Council Regulation (EC) 139/2004 on February 7, 2017 and adopted by the European Commission in its decision of March 27, 2017 in Case M.7932. “Environmental Laws” means, collectively, any and all Laws and Judgments relating to Contamination or protection of human health or safety or the environment, including Laws relating to the exposure to, or Release, threatened Release or the presence of Hazardous Substances, or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, transport or handling of Hazardous Substances and all Laws with regard to recordkeeping, notification, disclosure and reporting requirements respecting Hazardous Substances. “Environmental Permit” means any permit, license, approval or other authorization under any applicable Law or of any Governmental Entity relating to Environmental Laws or Hazardous Substances. “ERISA” means the Employee Retirement Income Security Act of 1974, as amended. “ERISA Affiliate” means, with respect to any entity, trade or business, any other entity, trade or business that is, or was at the relevant time, a member of a group described in Xxxxxxx

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.

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.