martes, 20 de septiembre de 2016

CDRH Industry: The FDA releases draft guidance on “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices”

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Today, the U.S. Food and Drug Administration released a draft guidance document entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.  This draft guidance is intended to help drug sponsors and device manufacturers coordinate the development of new antimicrobial drugs and antimicrobial susceptibility test devices (AST), so that FDA antimicrobial drug approval and AST device clearance may occur more closely in time.  The draft guidance is intended to address concerns that new FDA-approved antibacterial drugs become available without needed FDA-cleared AST devices because of a potential time lag between the drug approval and device clearance.
The draft guidance clarifies the process for coordinated development by:
  • Providing recommendations to help aid antibacterial drug developers and AST device manufacturers in working together to streamline the clearance process.
  • Highlighting considerations for submitting separate applications to the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) when seeking to facilitate clearance of an AST device as close in time as possible to antimicrobial drug approval.
  • Explaining that new antimicrobial drug products and AST device(s) will still undergo separate review, and coordinated development will not change the review timeline for either product.
The FDA will host a public workshop regarding Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices on Thursday, September 29 from 9:00 a.m. to 4:00 p.m. at the Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. This public workshop is intended to facilitate discussion between drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs or AST devices and who wish to coordinate development of these products.
Comments on the draft guidance can be submitted for 60 days from the date of publication via http://www.regulations.gov, or sent in writing to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
If you have general questions about this guidance, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov. For questions for CDER, contact Joseph Toerner at 301-796-1400, or joseph.toerner@fda.hhs.gov.
Thank you,
Food and Drug Administration
Center for Devices and Radiological Health

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