FDA Finalizes Guidance Laying Out Categories For ANDA Amendments

FDA published final guidance on Wednesday (July 3) that sets out classifications and categories for amendments to generic drug applications and how amendment submissions may affect an application's review goal dates. While FDA incorporated some industry-requested changes from the draft version into the final version, the timelines for submitting certain types of data and the majority of criteria for fitting into certain categories largely remain the same between draft and final guidance. FDA published its final guidance, "ANDA Submissions --...