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GUIDANCE DOCUMENT

Integrated Summary of Effectiveness October 2015

Download the Final Guidance Document
Final
Docket Number:
FDA-2008-D-0449
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance describes the recommended content of the integrated summary of effectiveness (ISE) for inclusion in a new drug application (NDA) or biologics license application (BLA).2 Although there are no regulations requiring an ISE for BLA submissions, applicants are encouraged to provide an ISE because it represents an opportunity to present a coherent analysis and presentation of the drug’s benefits.

Submit Comments

Submit Comments Online

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-2008-D-0449.

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