The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled, Using the Inactive Ingredient Database. Under the reauthorization of the Generic Drug User Fee Amendments, the FDA committed to enhancing the Inactive Ingredient Database (IID) by October 1, 2020. The FDA is issuing this draft guidance and establishing a docket in order to provide an opportunity for public comment before the enhancements to the database are completed.
The IID provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing new drug products, as once an inactive ingredient is used in approved drug products for a particular route of administration, the inactive ingredient is not considered novel and may require a less extensive review the next time it is included in a new drug product. This will help development and assessment of new drug applications. The draft guidance also supports our Drug Competition Action Plan, as well as commitments we made when the Generic Drug User Fee Amendments (GDUFA) were reauthorized to promote the efficiency and effectiveness of the generic drug development and application assessment process.
This draft guidance explains how industry should use the IID in the development of drug products. The guidance also describes how the FDA uses the IID to support inactive ingredients safety, which affects application filing and scientific review decisions. In addition, this guidance discusses how the IID is structured; the process for adding inactive ingredients to the IID; and how nomenclature, maximum potency levels, and units of measure are presented in the IID. Lastly, the guidance is intended to give IID users a clearer understanding of the database’s benefits and limitations.
To comment on the draft guidance, please visit the public docket, 2019-14780.
FDA is announcing the availability of a draft guidance for industry entitled, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process. Part of the drug application approval process includes compliance with the official compendium, the United States Pharmacopeial Convention-National Formulary (USP-NF), if applicable. This guidance assists applicants in the initiation of either revisions to an existing monograph(s) or development of a new monograph(s) under the USP-Pending Monograph Process (USP-PMP) during FDA’s evaluation of a drug substance master file or drug product application.
Before the USP-PMP launched, if during the review of a drug application it was clear that the proposed specifications would not comply with the current monograph, approval of the application and patient access to the drug were delayed because the USP-NF standards development processes did not accept proposals from applicants requesting changes to compendial standards for products that were not currently approved by FDA. If a monograph needed to be revised to include the applicant’s proposed specifications, there were no mechanisms to do this until after the application was approved. Typically, the revised monograph would not become official for 6 months or more. The USP-PMP was created to address these issues. 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.
The draft guidance and the USP-PMP support our Drug Competition Action Plan, as well as commitments we made when the Generic Drug User Fee Amendments (GDUFA) were reauthorized to promote the efficiency and effectiveness of the application assessment process.
To comment on the draft guidance, please visit the public docket, 2019-14781.
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