For ANDAs, Pre-Submission Facility Correspondence Has Improved, But Still Not Ideal
US FDA wants the program, intended to help speed ANDA approvals, utilized more, but industry still questions the information that must be submitted.
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Both issues have been the subject of questions and criticism as the FDA and industry attempt to boost generic competition.
Amid confusion about multiple priority and expedited pathways for US generic drug applications, industry asks which are a true advantage.