FDA Published ANDA Submission Guidance

On Dec. 21, 2016, FDA published its guidance on refuse-to-receive standards for abbreviated new drug application (ANDA) submissions. The guidance was developed to assist ANDA applicants and applicants of prior approval supplements (PASs) to ANDAs in preparing submissions. Deficiencies that may result in an FDA refuse to receive (RTR) are highlighted.

FDA may issue a RTR decision if the agency feels that an ANDA is not complete enough for the agency to perform a substantive review. ANDA deficiencies that FDA has observed, and the agency’s assessment of these deficiencies, are described.

The guidance includes a long list of RTR deficiencies in a variety of areas. Some of the deficiencies mentioned in the guidance include the following:

• Not formatting the ANDA according to the eCTD format

• Outstanding user fee obligations

• Lack of a designated US agent for a foreign applicant

• Starting material for an API is not justified according to the principles in the International Council for Harmonization (ICH) Q11 guidance

• Missing sterility data

• Inadequate stability

• Deficiencies related to microbiology considerations.

• Failed in vivo bioequivalence studies.

The guidance also provides advice for disputing RTR decisions. An appendix offers examples of minor deficiencies.

Source: FDA