• FDA's ANDA submission criteria to avoid Refuse to Receive (RTRs)

    In recent times, it has been observed that high number of generic drugs are being approved by the United States Food and Drug Administration (US FDA). In parallel, there are also instances of Refuse to Receive (RTR) from the health authority. It might be due to missing or misleading information provided in the Abbreviated New Drug Application (ANDA) Submissions.