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U.S. Department of Health and Human Services

Drugs

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Questions and Answers Regarding the Complete Response Letter Rule

1. What is the most significant change resulting from the finalization of this rule?

FDA will now begin issuing complete response letters when communicating a decision to a drug company that its new drug application (NDA) or abbreviated new drug application (ANDA) to market a new or generic drug will not be approved in its present form.  Currently FDA issues either approvable or not approvable letters in these cases.  Complete response letters will only be issued for applications that are not approved; this rule will not impact how FDA communicates decisions to approve an application.

2. Why is FDA adopting the use of complete response letters?

A complete response letter provides a more consistent and neutral mechanism to convey that our initial review of an application is complete and we cannot approve the application in its present form.  It provides a more consistent approach to informing applicants of changes that must be made before an application can be approved, with no implication regarding the ultimate approvability of the application.  The adoption of complete response letters is one of the Agency’s commitments under the Prescription Drug User Fee Act (PDUFA).

3. Will this rule change how FDA communicates decisions to not approve a marketing application for a biologic product?

No; FDA has been issuing complete response letters for all products for which marketing approval is sought under a biologics license application since 1998.

 4. Will this rule change anything else about how FDA conducts the review of marketing applications?

The rule includes additional regulations regarding changes to:
  • the Agency’s ability to defer the review of amendments,
  • extensions of the review cycle due to the submission of a major amendment,
  • classification of responses to a complete response letter (i.e., Class 1 and Class 2 resubmissions),
  • timelines for submitting a response to a complete response letter and administrative actions for a failure to respond, and
  • the definition of an efficacy supplement. 
For the most part, however, these changes to regulations will codify existing policies and procedures in place at both CBER and CDER concerning the review of marketing applications, rather than change those policies and procedures.

5. When will the changes in this rule go into effect?

Beginning August 11, 2008, FDA will no longer issue approvable and not approvable letters, regardless of when the application was submitted.