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Analgesic Indications: Developing Drug and Biological Products February 2014


Not for implementation. Contains non-binding recommendations.

Analgesic Indications: Developing Drug and Biological Products

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

This guidance provides recommendations to sponsors on the development of prescription drugs that are the subject of new drug applications (NDAs) for the management of acute and chronic pain as well as the management of breakthrough pain (hereafter analgesic development). Specifically, this guidance focuses on clinical drug development and trial design issues and chemistry, manufacturing, and controls (CMC) concerns that are unique to the study of acute, chronic, and breakthrough pain and the labeling considerations for analgesic drugs. This draft guidance is intended to serve as a focus for continued discussions on relevant issues among the Division of Anesthesia, Analgesia, and Addiction Products, pharmaceutical sponsors, the academic community, and the public.

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.