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FDA Revises Process for Responding to Drug
Applications
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The U.S. Food and Drug Administration today announced
that it is revising the way it communicates to drug companies
when a marketing application cannot be approved as
submitted.

Under new regulations that govern the drug approval
process, FDA's Center for Drug Evaluation and Research
(CDER) will no longer issue "approvable" or "not approvable"
letters when a drug application is not approved. Instead,
CDER will issue a "complete response" letter at the end of the
review period to let a drug company know of the agency's
decision on the application.

"These new regulations will help the FDA adopt a more
consistent and neutral way of conveying information to a
company when we cannot approve a drug application in its
present form," said Janet Woodcock, M.D., director of the
agency's Center for Drug Evaluation and Research (CDER).
"Thorough and timely review of drug applications is a priority
of the FDA, and these new processes will make our
communications with sponsors of applications more
consistent."

Taking the place of "approvable" and "not approvable"
letters, a "complete response" letter will be issued to let a
company know that the review period for a drug is complete
and that the application is not yet ready for approval. The
letter will describe specific deficiencies and, when possible,
will outline recommended actions the applicant might take to
get the application ready for approval.

Currently, when assessing new drug applications, the FDA
can respond to a sponsor in one of three types of letters: an
"approval" letter, meaning the drug has met agency
standards for safety and efficacy and the drug can be
marketed for sale in the United States; an "approvable" letter,
which generally indicates that the drug can probably be
approved at a later date provided that the applicant provides
certain additional information or makes specified changes
(such as to labeling); or a "not approvable" letter, meaning
the application has deficiencies generally requiring the
submission of substantial additional data before the
application can be approved.

"Complete response" letters are already used to respond to
companies that submit biologic license applications. The
process for drugs and biologics will be consistent under the
new regulations.

The revision should not affect the overall time it takes the
FDA to review new or generic drug applications or biologic
license applications. These changes, which will become
effective on Aug. 11, 2008, are not expected to directly affect
consumers.

In July 2004, the FDA issued a proposed rule on these topics.
At that time the agency asked for comments on the proposal.
Today's final rule addresses comments submitted to the
agency.