Harmonizing
Compendial Standards With Drug Application Approval Using the USP Pending
Monograph Process - new FDA Guidance for
Industry.
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.2 This guidance describes the process that allows for the revision
of compendial standards that are harmonized with the approved quality and
labeling requirements for a drug product application.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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