Want To Avoid A Refuse-To-File? Submit ANDA In English, FDA Says
Generic applications continue to be tripped up by failing to adhere to other well-known standards such as paying user fees, US agency says.
You may also be interested in...
Algorithms are intended to help predict incoming workload, which will be used to help set user fees.
Refuse-to-receive rates for ANDAs are down, suggesting sponsors better understand the standards for quality applications, Office of Generic Drugs Director Sally Choe says in first speech to industry.
Kathleen Uhl says applicants can avoid RTRs by conducting quality checks before submission, but sponsors may have difficulty changing their approach because of how fundamental application speed is to their business model.