federal_register: E8-16638
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| E8-16638 | Food and Drug Administration Critical Path Workshop on Clinical Trials for Local Treatment of Breast Cancer by Thermal Ablation | Notice | The Food and Drug Administration (FDA) is announcing a public workshop to discuss the issues associated with the development and implementation of feasibility trials for local treatment of breast cancer by thermal ablation (i.e., cryoablation, focused ultrasound, interstitial laser, microwave, radiofrequency ablation). We are inviting individuals, companies, organizations, and other stakeholders to attend this public workshop to discuss how standardized protocols for evaluation of tissue biopsy pathology, selection of tumors amenable to ablation, image guidance for ablation, post-ablation imaging and assessment, and tissue pathology of ablated specimens can be developed and used in breast cancer thermal ablation clinical trials. The public workshop will also serve as a forum for discussing where within the multispecialty care path involving operative therapy, chemotherapy, and radiation therapy, thermal ablation may play a role. Date and Time: The public workshop will be held on September 15, 2008, from 9 a.m. to 6 p.m. Online registration is available at http:// www.blsmeetings.net/2008ThermalAblationWorkshop until 5 p.m. on August 30, 2008 (see section III of this document for details). Location: The public workshop will be held at the FDA White Oak Campus, conference rooms 2047 F and G (http://grouper.ieee.org/groups/ scc34/sc2/meeting--info/Meeting--WhiteOak--15-18OCT2007/White--Oak-- Campus--Info--2007.pdf) located at 10903 New Hampshire Ave., Silver Spring, MD 20993. Contact: Binita Ashar, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3600, e-mail: Binita.Ashar@FDA.HHS.gov. If you need special accommodations due to a disability, please contact Paula Gumbs at 301-594-4453 at least 7 days in advance. | 2008-07-21 | 2008 | 7 | https://www.federalregister.gov/documents/2008/07/21/E8-16638/food-and-drug-administration-critical-path-workshop-on-clinical-trials-for-local-treatment-of-breast | https://www.govinfo.gov/content/pkg/FR-2008-07-21/pdf/E8-16638.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing a public workshop to discuss the issues associated with the development and implementation of feasibility trials for local treatment of breast cancer by thermal ablation (i.e., cryoablation, focused... |