Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA

On 24 November 2020 the FDA announced the availability of the final guidance for industry.

This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated new drug application (ANDA) for a complex product, as defined in this guidance. Specifically, this guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA.

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