Limited population pathway for antibacterial and antifungal drugs
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services. issuing body. United States. Food and Drug Administration. issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Drug Evaluation and Research, August 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Anti-Bacterial Agents Antifungal Agents Legislation, Drug United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- 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). Section 506(h)(5) of the FD&C Act requires FDA to issue guidance “describing criteria, processes, and other general considerations for demonstrating the safety and effectiveness of limited population antibacterial and antifungal drugs." This guidance provides this information and is intended to assist sponsors4 in the development of certain new antibacterial and antifungal drugs for approval under the LPAD pathway. This guidance also is intended to assist applicants in developing labeling, including prescribing information, patient labeling, and carton/container labeling, that incorporates certain statements required by section 506(h). This guidance does not address specific recommendations on the design of clinical trials for drugs developed under the LPAD pathway. That topic is addressed in the guidance for industry Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases (August 2017) (Unmet Medical Need guidance).
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (14 pages)).
- NLM Unique ID:
- 9918227360706676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918227360706676