Tuesday, October 28, 2014

FDA aims to better communicate with trial sponsors through out trial process

The FDA is striving to meet a newer, emerging market of drug development by establishing an open line of communication so that sponsors of clinical trials can maintain an efficient and effective drug discovery and trial process.

On this timeline, by the end of this fiscal year, here are a few of the items that the FDA has set up in order to better facilitate clinical trials:

  • - Timely interactive communication with sponsors during drug development is a core activity to help achieve our mission to facilitate the conduct of efficient and effective drug development programs
  • -Set up best practices for triage of sponsor requests for advice from the review team and timely communication of responses
  • - OND liaison staff in facilitating overall enhanced drug development communication between CDER and the drug development sponsor community

And more. You can see the entire report on the goals for this effort at the FDA's release.

Will having direct access to communicate with the FDA during clinical trials will enhance the process?

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