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

Description

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.2This 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.

Scope & Applicability

Regulatory Context

• 21CFR299.5§ 299.5 Drugs; compendial name.

  (a) The name by which a drug is designated shall be clearly distinguishing and differentiating from any name recognized in an official compendium unless such drug complies in identity with the identity prescribed in an official compendium under such recognized name.Read full regulation →

• 21CFR314.430§ 314.430 Availability for public disclosure of data and information in an application or abbreviated application.

  (a) The Food and Drug Administration will determine the public availability of any part of an application or abbreviated application under this section and part 20 of this chapter . For purposes of this section, the application or abbreviated application includes all data and information submitted wRead full regulation →

• 21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.

  (a) Filing an NDA.Read full regulation →

• 21CFR514.110§ 514.110 Reasons for refusing to file applications.

  (a) The date of receipt of an application for a new animal drug shall be the date on which the application shall be deemed to be filed.Read full regulation →

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