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The US Food and Drug Administration 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, a FDA press release
said.
"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 labelling); 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.
(Ref: Chronicle Pharmabiz dated 12 July 2008) |
