Federal Register #FDA-2017-D-5974

FDA Draft Guidance Announcement: ANDA vs. 505(b)(2) Drug Application Pathways

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has released a draft guidance for industry regarding drug application submission pathways. - Government Buyer: - Food and Drug Administration (FDA) - Department of Health and Human Services - Purpose: - Announcement of draft guidance titled "Determining Whether to Submit an ANDA or a 505(b)(2) Application" - Guidance assists applicants in choosing the correct abbreviated approval pathway for marketing drug applications - OEMs and Vendors: - No OEMs or vendors are mentioned - Products/Services Requested: - No products or services are being procured - No part numbers or quantities specified - Unique Requirements: - The draft guidance updates and will replace the 2019 version when finalized - Public comments are requested on the draft guidance - Notable Details: - The notice is informational and does not involve procurement or purchasing activities

Description

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled "Determining Whether to Submit an ANDA or a 505(b)(2) Application." This draft guidance is intended to assist applicants in determining the appropriate abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act for submitting a marketing application to FDA. It revises the 2019 guidance and will replace it when finalized. Comments on the draft guidance are requested by October 19, 2026.

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