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- B43cd144dbdb9d35c7481bddbb6956017 NCIT_P378 "FDA" @default.
- B43cd144dbdb9d35c7481bddbb6956017 NCIT_P381 "eCTD" @default.
- B43cd144dbdb9d35c7481bddbb6956017 type Axiom @default.
- B43cd144dbdb9d35c7481bddbb6956017 annotatedProperty NCIT_P325 @default.
- B43cd144dbdb9d35c7481bddbb6956017 annotatedSource NCIT_C70877 @default.
- B43cd144dbdb9d35c7481bddbb6956017 annotatedTarget "A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) 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. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these." @default.