The purpose of this guidance is to assist sponsors that are developing local anesthetic drug products to produce postoperative analgesia for a prolonged duration, for which submission of a new drug application (NDA) through the pathway described in section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) is appropriate.
FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
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