FDA's Complete Responses Commence

Rockville, MD (Aug. 7)-Next week, the US Food and Drug Administration’s communications with pharmaceutical companies will change. Under new regulations that govern the drug approval process, 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, according to an FDA release. Instead, CDER will issue a “complete response” letter at the end of the review period to let a drug company know of the agency’s decision on the application. The change takes effect August 11.

“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 CDER Director Janet Woodcock in the release. “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.”

A “complete response” letter will let a pharmaceutical company know that the review period for its submitted drug is complete but that the application is not yet ready for approval. The letter will describe specific deficiencies and, when possible, outline ways the company might improve the application to make it approval-ready.

When assessing new drug applications, FDA currently responds with one of the following: an “approval” letter, meaning the drug has met agency standards for safety and efficacy and the drug can be marketed for sale in the United States; an “approvable” letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to labeling); or a “not approvable” letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before the application can be approved.

“Complete response” letters are currently used to respond to companies that submit biologic license applications. The new regulations will make the process for drugs and biologics consistent.

Read the full complete response final rule.

Read PharmTech’s related blog post on this topic.