DMF definition
DMF means a drug master file, as provided for in 21 CFR § 314.420 or similar submission to or file maintained with the FDA or other Governmental Authority or Regulatory Authority that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.
DMF means a Drug Master File maintained with the FDA or its equivalent maintained with a Regulatory Authority in other countries within the Territory.
Examples of DMF in a sentence
Just hereby grants to Client the right to reference such DMF in support of regulatory filings related to the subject matter of this Agreement, and upon the request of Client, Just shall authorize, and hereby authorizes, Regulatory Authorities to permit such DMF to be incorporated by reference in such regulatory filings of Client.
More Definitions of DMF
DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.
DMF means a Drug Master File for Captisol, as filed as of the Effective Date, or as hereafter updated from time to time during the Term, by CyDex with the FDA.
DMF means a Drug Master File.
DMF means a Drug Master File as described in 21 C.F.R. § 314.420.
DMF means a version of the United States Social Security Administration’s Death Master File or any other database or service that is at least as comprehensive as the United States Social Security Administration’s Death Master File for determining that a person has reportedly died. The Death Master File must include at least one full version of the file and may include update files.
DMF means a Drug Master File in the United States or equivalent filing or filing serving a similar purpose in another regulatory jurisdiction.