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# Changes Sought in LPAD Draft Guidance
- URL: https://www.fdaweb.com/changes-sought-in-lpad-draft-guidance/
- Published: 2018-08-16T12:00:00.000Z
- Updated: 2026-09-15T00:26:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142124

Pharmaceutical Research and Manufacturers of America [says](https://www.regulations.gov/document?D=FDA-2018-D-2032-0012&ref=fdaweb.com) it generally supports the FDA proposed limited population pathway for antibacterial and antifungal drugs (LPAD) and provides comments on the draft guidance: need for revisions to accurately reflect statutory language; FDA LPAD pathway eligibility determinations made at a time of approval may discourage pathway use based on sponsor uncertainty; FDA should not inadvertently discourage development under the pathway of medicines to treat rare diseases.

The Biotechnology Innovation Organization [says](https://www.regulations.gov/document?D=FDA-2018-D-2032-0008&ref=fdaweb.com) the draft guidance provides welcome clarity for sponsors developing antibiotic and antifungal drugs under the pathway created by the 21st Century Cures bill. It offers these comments: additional examples of products for which the LPAD approval pathway might be valuable or necessary would be helpful; additional clarification is needed to inform clinical trial design for LPAD products; FDA should consider how new initiatives to modernize drug development and review may be applied to LPAD products; additional guidance is requested on labeling; and clarity is needed on communication of promotional material.