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FDA revises process for responding to drug applications
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The U.S. Food and Drug Administration has revised the way it responds to drug companies when a marketing application cannot be approved as submitted, the agency announced.
Under these new drug approval regulations, the 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, the CDER will issue a "complete response" letter at the end of the review process to inform a drug company of the agency's decision, according to a press release from the agency.
The complete response letter will inform a company that the review period for a drug is complete and that the application is not yet ready for approval. The letter will explain specific deficiencies and, when feasible, will outline suggested measures to prepare the application for approval.
Presently, the FDA can respond to new drug applications through one of three types of letters: an approval letter, meaning the drug has met safety and efficacy standards and can be marketed in the United States; an approvable letter, which indicates that the drug can probably be approved at a later date provided that certain additional information or modifications are made; or a not approvable letter, meaning the application has deficiencies 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 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," Janet Woodcock, MD, director of the CDER, said in the release. "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."
The FDA does not expect these revisions to influence the time it takes to review new or generic drug applications or biologic license applications, nor does it expect the revisions to directly affect consumers.
The changes will become effective on Aug. 11, according to the release.