On January 17, 2017, the FDA published the draft guidance for industry entitled “Referencing Approved Drug Products in Abbreviated New Drug Application (ANDA) Submissions.” This guidance is intended to help potential ANDA applicants understand and accurately use terms relating to ANDAs, specifically reference listed drug (RLD), reference standard, and basis of submission. It also describes the process for requesting FDA designation of an RLD and FDA selection of a reference standard.
The FDA is issuing this draft guidance because a variety of factors, including the discontinued marketing of many approved drug products and FDA’s identification of certain reference standards as RLDs in the printed and electronic version of FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book), has led to confusion surrounding these terms and the information to be included in an ANDA. This guidance will be of interest to the holders of pending or approved ANDAs and future ANDA applicants. The FDA anticipates that this guidance will help applicants understand the meaning of terms related to ANDA submissions and help them identify the previously approved products that need to be referenced in an ANDA submission, thereby facilitating the submission and review of ANDAs.
Additionally, the FDA intends to record a webinar to walk applicants through this guidance. The presentation and accompanying slides will be posted on FDA.gov.
To comment on the draft guidance, please visit the public docket, FDA-2017-D-0114.
Direct link to the draft guidance: http://www.fda.gov/downloads/
Drugs/ GuidanceComplianceRegulatoryIn formation/Guidances/UCM536962. pdf