Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Development of Local Anesthetic Drug Products With Prolonged Duration of Effect.” The draft guidance reflects the Agency’s current recommendations regarding drug development and trial design issues relevant to the study of local anesthetic drug products with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.
Scope & Applicability
Product Classes
7Drug products developed for postoperative analgesia; Guidance focuses on development programs for local anesthetic drug products for postoperative analgesia.
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Complex dosage forms that may require one batch per strength for evaluation
Efficacy and safety studies are necessary for the first modified-release formulation.
Comparison point for modified-release formulations.
Development of local anesthetic drug products with prolonged duration of effect
Two or more active ingredients combined at a fixed dosage
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
6Explanation of the basis for this margin if a noninferiority trial is used
Characteristic of the local anesthetic drug products being discussed; Characteristic of the local anesthetic drug products under development
Pharmacokinetic profile including systemic drug exposure.
time to reach peak exposure
Cmax may be more informative for safety
AUC or Cmin may correlate with efficacy
Identified Hazards
Hazards
2Risk of systemic exposure that must be assessed
Risk of local exposure at the site of administration
Related CFR Sections (3)
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR4.2§ 4.2 How does FDA define key terms and phrases in this subpart?
The terms listed in this section have the following meanings for purposes of this subpart:Read full regulation →
- 21CFR300.50§ 300.50 Fixed-combination prescription drugs for humans.
The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows:Read full regulation →
Related Warning Letters (4)
- 2025-03-18
CGMP/Finished Pharmaceutical/Adulterated
Advanced Pharmaceutical Technology
- 2024-08-27
CGMP/Drugs/Adulterated
EyePoint Pharmaceuticals, Inc.
- 2024-08-06
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Omega Tech Labs LLC
- 2021-06-29
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Aquavit Pharmaceuticals, Inc
See Also (8)
- General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- ICH Q12: Implementation Considerations for FDA-Regulated Products: Draft Guidance for Industry (Status: Draft)
- Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry (Status: Draft)
- Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry (Status: Final)
- Development of New Stereoisomeric Drugs (Status: Final)
- Format and Content of the Clinical and Statistical Sections of an Application (Status: Final)