On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s ...
The US FDA has issued its latest guidance on abbreviated new drug applications (ANDA) submissions on content and format to stall common recurring deficiencies. The regulatory authority insists that ...
On Thursday, 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“Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance.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 ...
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