The U.S. Food and Drug Administration announced that it has revised its method of communicating that a drug cannot be approved as submitted to pharmaceutcial companies.
Previously the FDA's Center for Drug Evaluation and Research (CDER) issued "approvable" or "non-approval" letters when a drug application was not approved. The new approval process will consist only of a "complete response" letter at the end of the review process to inform the drug company of the agency's decision.
"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."
The change in the application response process is not expected to affect the time it takes the FDA to review nor will it directly affect consumers. The changes become effective August 11, 2008.
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