US FDA Largely Stands Pat In Revised ANDA Submission Guidance
Executive Summary
Agency made few of industry's requested changes regarding when it would refuse to receive generic applications, but the absence of comments from several big generics companies indicates some level of satisfaction.
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US FDA Outlines Internal ANDA Refuse-To-Receive Policy
Manual of Policies and Procedures document should provide more help to sponsors on what items must be in an ANDA for it to be reviewed.
US FDA Outlines Internal ANDA Refuse-To-Receive Policy
Manual of Policies and Procedures document should provide more help to sponsors on what items must be in an ANDA for it to be reviewed.
Generic Application Quality Showing Signs Of Improvement
US FDA’s monthly refuse-to-receive numbers for ANDAs are down early in FY 2017, suggesting that sponsor have an increased understanding of the agency’s standards.