US FDA chanages way of respondig to NDAs, dropping "approvable" status

In a move that will see the end of the euphemistic term "approvable letter," the US Food and Drug Administration has said that it will revise the way it communicates to pharmaceutical companies when a marketing application cannot be cleared as submitted.

Under new regulations that govern the drug approval process, the FDA's Center for Drug Evaluation and Research will no longer issue "approvable" or "not approvable" letters when a drug application is not cleared. Instead, the CDER will issue a "complete response" letter at the end of the review period to let a drugmaker know 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, Director of the 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," she added.