- Technical Electronic Product Radiation Safety Standards Committee
Meeting Date: 5/22/02-5/22/02
The committee will hear an informal review of ongoing activities associated with electronic products. Following the overview, FDA will discuss its concern about radiation doses associated with x-ray computed tomography (CT), and its current thinking about amending the U.S. performance standard for x-ray CT imaging procedures. Specifically FDA will address possible requirements for: (1) definition and standardization of CT terminology; (2) display of an index of patient radiation dose that could be automatically recorded within a facility quality assurance program; (3) automatic exposure control through modulation of x-ray tube output according to patient dimensions; and (4) limitation of the x-ray field size to that needed for image formation. In the afternoon, FDA will discuss proposed amendments to the U.S. performance standard for sunlamp products and certain initiatives of international standards organizations concerning sunlamp products. In the final session, FDA will be considering mandatory standards for x-ray security screening systems; FDA will discuss public health considerations regarding these systems that use ionizing radiation.
|Location:||Hilton Gaithersburg, MD||Related News Links:||Not Available|
- Oncologic Drugs Advisory Committee
Meeting Date: 2/9/21-2/9/21
The committee will discuss supplemental biologics license application (sBLA) 125514/s-089, for KEYTRUDA (pembrolizumab), submitted by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. The proposed indication (use) for this product is for the treatment of patients with high-risk, early-stage triple-negative breast cancer, in combination with chemotherapy as neoadjuvant treatment, then as a single agent as adjuvant treatment after surgery. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.
|Location:||Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.||Related News Links:||Not Available|