Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA

This guidance provides recommendations to industry on product-specific guidance (PSG) meetings 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) under section 505(j) of the Federal Food, Drug and Co

Source: FDA Center for Drug Evaluation and Research - What's New - February 24, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news