FDA seeks neutral ground for drug non-approval

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The FDA, as of August 11, is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

Under the new drug approval process 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, CDER will issue a  “complete response” letter at the end of the review period to let a drug company know why the agency will not presently approve the drug.   

“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, MD, director of the agency’s 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.”

Complete response letters to drugmakers will:

  • State that the FDA will not approve the new drug application (NDA) or abbreviated NDA (ANDA) in its present form;
  • Describe all specific deficiencies that the FDA has identified in the application, except when the agency determines the data submitted are inadequate to support approval;
  • Include a complete review of data in the NDA or ANDA and any amendments; and
  • If possible, recommend actions the applicant might take to make the application eligible for approval.

The revision should not affect the overall time it takes the FDA to review new or generic drug applications or biologic license applications. The changes are not expected to directly affect consumers.