federal_register: E9-24828
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| E9-24828 | Advancing Clinical Development of Molecular and Other Diagnostic Tests for Respiratory Tract Infections; Notice of Public Workshop | Notice | The Food and Drug Administration (FDA) is announcing a public workshop, co-sponsored with the Infectious Diseases Society of America (IDSA), regarding scientific issues in the development of molecular and other tests for the diagnosis of respiratory infections, entitled "Advancing Clinical Development of Molecular and Other Diagnostic Tests for Respiratory Tract Infections." The purpose of the public workshop is to provide an opportunity to share information and perspectives with health care providers, academia, and industry on various aspects of diagnostic test development for respiratory infections. Topics for discussion will include the role of emerging diagnostic tests in promoting appropriate use of antibiotics by physicians, the use of novel diagnostic tests in the study of new drugs for respiratory infections, and the possible contribution of biomarkers in the approach to treatment of respiratory infections. Date and Time: The public workshop will be held on November 12, 2009, from 8 a.m. to 6 p.m. and on November 13, 2009, from 8 a.m. to 4:30 p.m. Location: The public workshop will be held at the Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD 20877. Seating is limited and available only on a first-come, first- served basis. Contact Person: Christine Kellerman, Center for Devices and Radiological Health, Food and Drug Administration, Office of In Vitro Diagnostic Devices, 10903 New Hampshire Ave., Building 66, rm. 5677, Silver Spring, MD 20993-0002, 301-796-5711. Registration: To register electronically, e-mail registration information (including: Name, title, firm name, address, telephone, and fax numbers) to Respdiagmtg@fda.hhs.gov by November 8, 2009. Persons without access to the Internet can call 301-796-5711 to register. Registration is free for the public workshop. Interested parties are encouraged to register early because space is limited. Seating will be available on a first-come, first-served basis. Persons needing a sign language interpreter or other special accommodations should notify Christine Kellerman (see Contact Person) at least 7 days in advance. Additional information is also available at http://www.fda.gov/ MedicalDevices/NewsEvents/WorkshopsConferences/ucm181140.htm. | 2009-10-15 | 2009 | 10 | https://www.federalregister.gov/documents/2009/10/15/E9-24828/advancing-clinical-development-of-molecular-and-other-diagnostic-tests-for-respiratory-tract | https://www.govinfo.gov/content/pkg/FR-2009-10-15/pdf/E9-24828.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing a public workshop, co-sponsored with the Infectious Diseases Society of America (IDSA), regarding scientific issues in the development of molecular and other tests for the diagnosis of respiratory... |