Thursday, 21 August 2014

FDA - Expedited Programs for Serious Condition



Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics

FDA is announcing the availability of a guidance for industry entitled “Expedited Programs for Serious Conditions—Drugs and Biologics”.

This guidance provides a single resource for information on FDA's policies and procedures related to the following expedited programs for serious conditions: (1) Fast track designation, (2) breakthrough therapy designation, (3) accelerated approval, and (4) priority review designation.

The guidance describes threshold criteria generally applicable to expedited programs, including what is meant by serious condition, unmet medical need, and available therapy. This guidance also discusses considerations for expedited development and review such as manufacturing and product quality, nonclinical studies, and clinical inspections. In addition, this guidance aligns CDER's criteria for priority review designation with CBER's criteria. Only products intended to treat a serious condition are eligible for priority review (unless otherwise eligible under specific statutory provisions).

For over 30 years, expediting the availability of promising therapies to patients with serious conditions has been a priority for FDA. With the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-122), FDA is expanding its efforts to expedite development and review of therapies intended to treat patients with serious conditions.

For more details, see FDA.

Posted by Tim Sandle