Development of Local Anesthetic Drug Products with Prolonged Duration of Effect

15 March 2023 – the FDA published the draft guidance on the development of local anesthetic drug products. Submit comments by 14 June 2023.

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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