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GUIDANCE DOCUMENT

How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD December 2014

Draft

Not for implementation. Contains non-binding recommendations.

How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance describes how a prospective abbreviated new drug application (ANDA) applicant 19 may request a letter stating that FDA has determined: (1) that the prospective applicant’s 20 bioequivalence (BE) study protocol contains safety protections comparable to those in the risk 21 evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) applicable 22 to the reference listed drug (RLD), and (2) that FDA will not consider it a violation of the REMS 23 for the RLD sponsor to provide a sufficient quantity of the RLD to the interested generic firm or 24 its agent to allow the firm to perform the testing necessary to support its ANDA.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.