The Food and Drug Administration (FDA) has revised its means for communicating when a marketing application cannot be approved as submitted. Under new regulations, 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 manufacturer know of the agency's decision on the application - 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, outline recommended actions the applicant might take to get the application ready for approval. Please click here to view the "complete response" regulation.