FDA Guidance for Industry: Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process

Titel:
FDA Guidance for Industry: Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process
Herkunft/Verlag:

FDA

Inhalt:
This guidance assists applicants and drug master file (MF) holders in the initiation of either revisions to an existing monograph(s) or development of a new monograph(s) under the United States Pharmacopeial Convention Pending Monograph Process (USP-PMP) during FDA’s evaluation of a drug master file or drug product application.

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