FDA publishes final guidance on ANDA/505(b)(2) NDA pathways

On 9 May 2019 the U.S. Food and Drug Administration (FDA) published the final guidance document, "Determining Whether to Submit an ANDA or a 505(b)(2) Application," that contains minor revisions to the October 2017 draft guidance.

The final guidance contains no significant changes to the draft version, but there are a few interesting tidbits.

Read More: FDA publishes final guidance on ANDA/505(b)(2) NDA pathways


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