federal_register: 2010-15814
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| 2010-15814 | Issues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development; Public Workshop | Notice | The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in the design and conduct of clinical trials for antibacterial drug development. The public workshop is intended to provide information for and gain perspectives from health care providers, researchers, academia, industry, and regulators on various aspects of design and conduct of clinical trials for antibacterial drugs. The workshop will focus on the design and conduct of non-inferiority (NI) clinical trials, which are often used in the evaluation of the safety and efficacy of a new antibacterial drug. The input from this public workshop will help in developing topics for further discussion. Date and Time: The public workshop will be held on August 2, 2010, from 8:30 a.m. to 5:30 p.m. and on August 3, 2010, from 8 a.m. to 4 p.m. Location: The public workshop will be held at the Crowne Plaza Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited and available only on a first-come, first-served basis. Contact Persons: Chris Moser or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, Office of Antimicrobial Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209, Silver Spring, MD 20993-0002, 301-796-1300. Registration: 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. To register electronically, e-mail registration information (including name, title, firm name, address, telephone and fax numbers) to abtrialworkshop@fda.hhs.gov. Persons without access to the Internet can call Chris Moser or Lori Benner at 301-796-1300 to register (see Contact Persons). Persons needing a sign language interpreter or other special accommodations should notify Christine Moser or Lori Benner at least 7 days in advance. | 2010-06-30 | 2010 | 6 | https://www.federalregister.gov/documents/2010/06/30/2010-15814/issues-in-the-design-and-conduct-of-clinical-trials-for-antibacterial-drug-development-public | https://www.govinfo.gov/content/pkg/FR-2010-06-30/pdf/2010-15814.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in the design and conduct of clinical trials for antibacterial drug development. The public workshop is intended to provide information for and gain... |