The US Food and Drug Administration is changing the way it tells drugmakers whether their marketing applications are likely to get a regulatory thumbs-up.

The agency’s Center for Drug Evaluation and Research says it will no longer issue ‘approvable’ or ‘not approvable’ letters but will inform firms through a ‘complete response’ letter at the end of the review period to let them know of the FDA's decision on an application.

The ‘complete response’ letter will be issued to let a company know that the application is not yet ready for approval. It will also describe “specific deficiencies” and, the FDA said, “when possible, will outline recommended actions the applicant might take to get the application ready for approval”.

Janet Woodcock, director of the CDER, said the new regulations, which will come into force on August 11, 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," She added that these “new processes will make our communications with sponsors of applications more consistent”.

The ‘complete response’ formula is already used to respond to companies that submit biologic license applications and the FDA said that the changes should not affect the overall time it takes to review new or generic drug applications or BLAs.