26 de junho de 2019

FDA PUBLIC MEETING to hold limited population pathway for antibacterial and antifungal drugs (LPAD pathway) public meeting

From: www.fda.gov

In the Federal Register for April 2, 2019, the U.S. Food and Drug Administration (FDA) announced a public meeting titled “Limited Population Pathway for Antibacterial and Antifungal Drugs.” The purpose of the meeting is to provide a public forum for the FDA to listen to comments on the draft guidance for industry, “Limited Population Pathway for Antibacterial and Antifungal Drugs,” that was published in the Federal Register on June 13, 2018. The FDA received many comments on the guidance and multiple requests for listening meetings with the FDA. As a result, the Agency will hold a public meeting on the LPAD pathway where stakeholders may present or comment on the draft guidance.

The FDA developed this draft guidance to assist sponsors in the development of new antibacterial and antifungal drugs by describing criteria, processes, and other general considerations required of drugs approved under the LPAD pathway. This guidance is intended to assist sponsors in developing labeling, including prescribing information, patient labeling and carton/container labeling for drugs approved under the LPAD pathway.

The public meeting will be held on Friday, July 12, 2019, from 9 a.m. to 3 p.m. EDT at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503A (the Great Room), Silver Spring, MD 20993.

For more information about the LPAD pathway public meeting, or to register to attend or present during the public comment session of the meeting, please visit: https://www.eventbrite.com/e/limited-population-pathway-for-antibacterial-and-antifungal-drugs-0lpad-public-meeting-tickets-54015228001