FDA In Brief: FDA provides guidance on improving the agency’s interactions with product developers to make the drug development process more informed and efficient

Dec. 28, 2017

Media Inquiries

"The rising cost of drug development has an impact on the price of medicines and affects patient access to health care. Set against the major promise offered by a new generation of more targeted medicines, we must look for ways to make the drug development process more efficient to make sure patients are able to access breakthroughs in a timely, affordable way. We must take these steps while also continuing to strengthen the FDA’s gold standard for assuring the safety of new drugs,” said FDA Commissioner Scott Gottlieb, M.D. “By engaging with product developers early, often before clinical research is underway or an application is submitted to the agency, the FDA’s scientific experts can share important advice on the proper design of clinical trials and other aspects of the development and regulatory process. This early and more thorough engagement can help innovators meet the FDA’s science-based requirements more effectively, meaning product developers will avoid costly delays that can unnecessarily impede access to beneficial new medicines."

Today, the U.S. Food and Drug Administration is announcing the availability of two guidances: a final guidance on “Best Practices for Communication Between IND Sponsors and FDA During Drug Development” and a draft guidance, “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of PDUFA Products.” Availability of these guidances fulfill essential goals set forth during this year’s reauthorization of the Prescription Drug User Fee Act (PDUFA).

Availability of the final guidance, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development,” will help support timely, transparent and effective communications between those submitting investigational new drug applications (INDs) and the FDA’s review staff at critical junctures in the drug development process. By collaborating with IND sponsors early in the application process, the FDA believes that its science-based feedback can make the drug development process more efficient, enabling patients to get timelier access to safe and effective new medicines. Specifically, the final guidance outlines the FDA’s philosophy towards timely and interactive communication with product developers who intend to submit an IND; it also examines the scope of appropriate interactions between the agency’s review staff and IND sponsors, the types of advice sponsors can seek from the FDA while pursuing their drug development programs, general expectations for the FDA’s response time, as well as best practices, appropriate methods and frequency of FDA-sponsor interactions.

Also issued today is the draft guidance, “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of PDUFA Products,” which provides recommendations for the conduct of formal meetings between the FDA and those developing new drug or biologic products. The FDA’s review staff already participate in many meetings of this nature each year. This draft guidance outlines efficient, consistent procedures for the timely and effective conduct of such meetings.

It is the FDA’s belief that availability of both guidances will support enhanced communication with drug developers, leading to enhanced transparency and efficiency to bring FDA-approved drugs and biological products to patients as quickly as possible, avoiding unnecessary delays.

For More Information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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