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CDER alters procedures.

ROCKVILLE, Md. -- Drug manufacturers whose products fail to win initial approval from the Food and Drug Administration are being notified in a new way, in part to avoid diminishing their investment appeal.

Under new regulations governing the drug approval process, the FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters.

Instead, CDER will issue a "complete response" letter at the end of a review period to let a pharmaceutical company know of the agency's decision on its application.

The change "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," says CDER director Dr. Janet Woodcock.

Thorough and timely review of applications is an FDA priority, "and these new processes will make our communications with sponsors of applications more consistent," she adds.

An overview of the new policy notes that some drug makers had expressed concern that a not-approvable letter "sent an unintended message that a marketing application would never be approved, which could adversely affect a company's ability to raise capital."

A complete response will describe specific deficiencies and, when possible, outline recommended actions for approval.

But because the letters are not made public, investors may get less information than they did when companies announced they had received an approvable or not-approvable letter, some analysts say. While companies may be better informed, investors will likely have no clues about a drug's status, they point out.

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 it 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 changes 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 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. Branded drug makers pay user fees in order for the agency to act on applications within 180 days. The modified rules include standards for review period extensions when companies file application amendments or resubmissions.

The changes, which became effective on August 11, are not expected to directly affect consumers.

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Title Annotation:Focus; Center for Drug Evaluation and Research
Publication:Chain Drug Review
Geographic Code:1USA
Date:Aug 18, 2008
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