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.
Posted by Tim Sandle
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