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

• Final Approval ProcedurePreparation, review and submission of Drug Master Files to Regulatory Authorities as per their specific requirements.

• DMF costs represent expenses incurred on development of processes and compliance with regulatory procedures of the USFDA, in filing Drug Master Files (DMF), in respect of products for which commercial value has been established by virtue of third party agreements/arrangements.

• Final Approval ProcedurePreparation, review, and submission of Drug Master Files to Regulatory Authorities as per their specific requirements.

• As of March 31, 2020, we have filed 123 Drug Master Files (“DMFs”) with the USFDA for our API products in multiple therapeutic areas, out of which 109 DMFs are active.

• I further authorize all institutions, employers, agencies and all governmental agencies and instrumentalities (local, state, federal or foreign) to release any information, files or records requested by the Committee.

More Definitions of Drug Master Files

Drug Master Files means the information submitted to the FDA as described in 21 C.F.R.

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