FDA Roundup: August 27, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

• On Monday, the FDA revised the Emergency Use Authorization for Pemgarda (pemivibart) to limit its use to when the combined national frequency of variants with substantially reduced susceptibility to Pemgarda is less than or equal to 90%. More information and resources about Pemgarda and its authorization are available on FDA’s website. 
• On Monday, the FDA announced registration has opened for the September 6 public meeting, “Advancing Treatments for Post-Traumatic Stress Disorder (PTSD).” This public meeting, with both virtual and in-person attendance options, will feature a panel discussion with federal partners to explore efforts to accelerate treatment development for PTSD, including psychedelic drug development. This meeting will also provide an opportunity for people with lived PTSD experience, including veterans, family members, and patient advocates; researchers and scientists; and drug developers to provide public comment.
• On Monday, the FDA posted a new video in the “FDA In Your Day” series. In this video, Chief Medical Officer, Dr. Hilary Marston discusses Lyme disease.
• On Friday, the FDA announced a webinar for the Final Guidance: Remanufacturing of Medical Devices that will be held on September 10, 2024, 1-2 p.m. ET. The FDA issued the final guidance as a part of its ongoing efforts to help explain the difference between remanufacturing and servicing. This guidance clarifies whether activities performed on devices are likely remanufacturing, which is different than servicing activities such as maintenance and repair. This clarification is intended to help ensure consistency and a better understanding of the regulatory requirements applicable to remanufacturers. Registration for the webinar is not required. 

Related Information

###