Issue Date: December 28, 2016
Issued by: Center for Drug Evaluation and Research
Topic(s): User Fees, Generic Drugs
Status: Final
ANDA Submissions — Refuse-to-Receive Standards Rev.2
This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to ANDAs for which the applicant is seeking approval of a new strength of the drug product.2 The guidance highlights deficiencies that may cause FDA to refuse to receive (RTR) an ANDA.3 An RTR decision indicates that FDA determined that an ANDA is not substantially complete.4 A substantially complete ANDA is “an ANDA that on its face is sufficiently complete to permit a substantive review.”5
Download the Guidance Document
