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GUIDANCE DOCUMENT

Development of Local Anesthetic Drug Products With Prolonged Duration of Effect March 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-0608
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Development of Local Anesthetic Drug Products With Prolonged Duration of Effect.” The draft guidance reflects the Agency’s current recommendations regarding drug development and trial design issues relevant to the study of local anesthetic drug products with prolonged duration of effect for which submission of a new drug application (NDA) is planned. The recommendations in the guidance are intended to assist developers in generating the data necessary to support different indications and labeling claims for these drugs.

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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-2023-D-0608.

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