U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry August 2020

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2018-D-2032
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This guidance provides information on the implementation of section 506(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 3042 of the 21st Century Cures Act, which established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway).

Submit Comments

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-2018-D-2032.

Back to Top