FDA Wants Input on How to Improve Clinical Trials Process for Industry

Regulatory NewsRegulatory News
| 28 October 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) wants the public's feedback on ways it can make it easier to communicate with the agency during the clinical trials process.

In an announcement in the Federal Register on 28 October 2014, FDA said it had established a docket at regulations.gov to allow it to receive comments from industry, the public and other organizations interested in formulating "best practices for communication between FDA and investigational new drug application (IND) sponsors during drug development."


INDs are used by drug companies to begin a clinical trial, and evidence from trials is later used as the basis of approval for new medicines.

Starting with the fifth iteration of the Prescription Drug User Fee Act (PDUFA)—a law passed in 2012 and intended to give FDA additional resources in return for a more predictable regulatory review process—FDA has pledged to reform certain elements of its IND review process.

"FDA’s philosophy is that timely interactive communication with sponsors during drug development is a core Agency activity to help achieve the Agency’s mission to facilitate the conduct of efficient and effective drug development programs, which can enhance public health by making new safe and effective drugs available to the American public in a timely manner," FDA wrote in its PDUFA Reauthorization Performance Goalsreport.

The agency has already been working to establish a liaison staff meant to help industry obtain quicker answers to questions that might otherwise hold up an IND or eventually derail a new drug application (NDA), such as if a trial looked at improper efficacy endpoints or enrolled too few patients.

Now, as the program enters into its third year, FDA says it wants to focus on the "identification and dissemination of best practices for enhanced communication." As explained in FDA's PDUFA report, FDA staff is set to eventually receive training on:

  • Best practices for triage of sponsor requests for advice from the review team and timely communication of responses to simple and clarifying questions or referral of more complex questions to the formal meeting process.
  • Best practices for communication between the review team and the sponsor including establishing clear expectations and agreement on appropriate mechanisms (e.g., when teleconferencing or secure email may be the most appropriate means of communication) and frequency of such communications.
  • The role of the OND liaison staff in facilitating overall enhanced drug development communication between CDER and the drug development sponsor community and the staff’s role in facilitating resolution of individual communication requests that have not been handled successfully in a timely manner by the review team, which is the primary interface with the sponsor regarding the drug under development.

New Guidance to be Developed

But the development of those "best practices" is set to be a collaborative effort. As FDA explains in its latest Federal Register announcement, it's interested in developing guidance that "will describe FDA's philosophy regarding timely interactive communication with IND sponsors as a core activity and the scope of appropriate interactions between the review team and the sponsor, outline the types of advice that are appropriate for sponsors to seek from FDA in pursuing their drug development program, describe the general expectations for the timing of FDA response to IND sponsor inquiries of simple and clarifying questions or referral of more complex questions to the formal meeting process."

Other goals of the guidance will be to "Describe best practices and communication methods (including the value of person-to-person scientific dialogue) to facilitate interactions between the FDA review team and the IND sponsor during drug development." FDA might also encourage teleconferencing or secure email in other situations, it said.

In theory, the advice should ensure that FDA moves expeditiously to clear or provide feedback on IND applications, allowing companies spend less time waiting to start a clinical trial and more time investigating new drugs to help patients.


FDA's Federal Register Notice


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