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GUIDANCE DOCUMENT

Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry January 2017

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2016-D-4412
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a proposed combination product that includes both a drug constituent part and a delivery device constituent part. The recommendations included in this guidance generally focus on the analysis of the proposed user interface for the generic drug-device combination product (generic combination product) when compared to the user interface for the reference listed drug (RLD). For the purposes of this guidance, the term user interface refers to all components of the combination product with which a user interacts. This includes the delivery device constituent part of the combination product and any associated controls and displays, as well as product labeling and packaging.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-4412 .

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