jueves, 22 de septiembre de 2016

FDA issues draft guidance on Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices- Drug Information Update

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Today, the U.S. Food and Drug Administration released a draft guidance document entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.” This draft guidance is intended to help drug sponsors and device manufacturers coordinate the development of new antimicrobial drugs and antimicrobial susceptibility test devices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 The draft guidance is intended to address concerns that new FDA-approved antibacterial drugs become available without needed FDA-cleared AST devices because of a potential time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The draft guidance clarifies the process for coordinated development by: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. 

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