The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Determining Whether to Submit an ANDA or a 505(b)(2) Application.'' This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) is appropriate for the submission of a marketing application to FDA.
Document
``Determining Whether To Submit an Abbreviated New Drug Application or a 505(b)(2) Application;'' Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Determining Whether to Submit an ANDA or a 505(b)(2) ...
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82 FR 47749
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“``Determining Whether To Submit an Abbreviated New Drug Application or a 505(b)(2) Application;'' Draft Guidance for Industry; Availability,” thefederalregister.org (October 13, 2017), https://thefederalregister.org/documents/2017-22196/determining-whether-to-submit-an-abbreviated-new-drug-application-or-a-505-b-2-application-draft-guidance-for-industry-a.