FDA Announces Guidance on Referencing Approved Drug Products in ANDA Submissions (US)
The FDA announced draft guidance to clarify the use of the reference listed drug, reference standard, and basis of submission in an abbreviated new drug application (ANDA).
by Practical Law Life Sciences
On January 17, 2017, the FDA announced draft guidance entitled Referencing Approved Drug Products in Abbreviated New Drug Application Submissions. Abbreviated new drug application (ANDA) applicants must include a basis of submission that identifies, among other things, the reference listed drug (RLD) and reference standard. The guidance aims to clarify these terms and how to identify them in an ANDA.
Under the guidance:
The RLD is the FDA-approved drug that the applicant seeks to duplicate. The FDA identifies drugs in the Orange Book that are eligible to be RLDs.
The reference standard, which is ordinarily the RLD, is the drug selected by the FDA that the applicant must use to conduct bioequivalence studies. The reference standard may differ from the RLD if the RLD is discontinued or not available in sufficient qualities for testing.
A basis of submission is the statement in the ANDA that includes the RLD. The reference standard, if different from the RLD, should be identified in the bioequivalence sections of the ANDA.
The guidance also addresses:
How an applicant can choose an RLD if the FDA has not designated one or if the applicant intends to refer to a pharmaceutical equivalent to the drug designated as an RLD in the Orange Book.
How an applicant can select a reference standard from those approved by the FDA or request that the FDA select a new reference standard.
How to identify the RLD and reference standard in the ANDA.
Comments on this guidance should be submitted by March 20, 2017.
Source: Federal Register: Referencing Approved Drug Products in Abbreviated New Drug Application Submissions; Draft Guidance for Industry; Availability, January 17, 2017.