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GUIDANCE DOCUMENT

Opioid Dependence: Developing Depot Buprenorphine Products for Treatment April 2018

Final

This guidance is being distributed for comment purposes only.

Opioid Dependence: Developing Depot Buprenorphine Products for Treatment

Docket Number:
2018-08361
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance reflects the Agency’s current thinking regarding drug product development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified-release products for injection or implantation) for the treatment of opioid use disorder (OUD). This guidance focuses on the development of depot buprenorphine products for which submission of a new drug application (NDA) through the pathway described in section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may be appropriate.


Submit Comments

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:

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

All written comments should be identified with this document's docket number: 2018-08361.