FDA revises refuse-to-receive guidance for ANDA submissions

The US FDA has further revised its guidance on abbreviated new drug applications (ANDAs) and the deficiencies that can cause FDA to refuse-to-receive (RTR) an application. An RTR decision indicates that FDA determined that an ANDA is not substantially complete.

This guidance is not positioned as a complete list of the deficiencies that may or will lead to an RTR decision by FDA. Rather, it identifies some recurrent deficiencies that in FDA’s experience have led FDA to RTR determinations. The information should help ANDA sponsors better understand what deficiencies may cause FDA to refuse to receive an ANDA. The guidance also lays out how FDA will assess deficiencies identified during its filing review to decide whether an ANDA should be ‘received’.

When a small number of minor deficiencies are identified, the usual process is that FDA provides the ANDA applicant with the chance to correct them or to amend an ANDA within seven calendar days. If the requested information is not received within this timeframe, FDA will RTR the ANDA. If FDA determines that an ANDA contains ten or more minor deficiencies or one or more major deficiencies, FDA will not consider the ANDA to be a substantially complete application. In such cases, the applicant will be told by FDA that they consider the ANDA not to have been ‘received.’ If the applicant decides to submit additional materials to correct the deficiencies, the resulting updated application will be considered a new ANDA submission, received as of the date the amended ANDA is submitted (if deemed substantially complete) and the applicant will be required to pay a new ANDA fee. If an ANDA is not received and the applicant takes no further action, FDA will consider the ANDA withdrawn one year later.

This revised guidance contains discussion on administrative, quality, bioequivalence and clinical deficiencies that FDA considers to be major deficiencies. Appendix A lists examples of minor deficiencies.

The updated guidance should help ANDA sponsors avoid RTR and non-received submissions.

To access the revised guidance, click here.