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FDA Proposes Changes to Drug Review Process Concerning Approvable, Not Approvable Letters

ROCKVILLE, MD -- July 19, 2004 -- The Food and Drug Administration (FDA) is proposing to change the new and generic drug review processes by replacing "approvable letters" and "not approvable letters" with "complete response letters" that provide companies with specific information about what needs to be done before their drugs can be approved for marketing. This approach has been used by FDA for biological drugs for some time and would be formalized for all drugs by this proposal.

These changes will ensure a single, consistent method of advising drug manufacturers that FDA review of an application is complete.

"This new approach will provide a clearer and more consistent method for communicating to new and generic drug applicants about the status of their applications," said Dr. Lester M. Crawford, Acting Commissioner of Food and Drugs.

In addition, the proposed rule would amend the provisions on extending the review cycle for amendments to an unapproved application and for starting a new cycle after a resubmission in answer to a "complete response" letter.

Under existing regulations, a resubmission of a new or generic drug marketing application extends the review period following receipt of an "approvable" or "not approvable" letter.

Under the new proposal, responses to "complete response" letters for new drug applications would be classified by what needs to be done to obtain marketing approval. A "Class 1" resubmission would be defined as an application resubmitted after receipt of a "complete response" letter that includes only certain items such as draft or final printed labeling, safety or stability updates, or other minor clarifying information. A "Class 1" resubmission would start a new, two-month review cycle.

A "Class 2" resubmission would be one that would require information beyond that called for in a "Class 1" resubmission (for instance, information that would need to be presented at a public advisory committee meeting). A "Class 2" resubmission would start a new, six-month review cycle.

The agency's proposal would retain the current "major" and "minor" terminology for resubmissions of generic drug applications. Under the proposal, a "major" generic drug marketing application resubmission would start a new, six-month review cycle. A "minor" generic drug application resubmission would start a new cycle of from 30 days to a few months, depending on the issues involved.

These changes to the regulations are proposed to implement the user fee performance goals referred to in the Prescription Drug User Fee Amendments of 2002 (known as PDUFA III) that address procedures and establish target timeframes for reviewing human drug applications.

In conjunction with the Prescription Drug User Fee Act of 1992 (PDUFA), FDA committed to meet certain goals for reviewing and deciding on human new drug applications. FDA's drug application review performance goals were revised with the enactment of the Food and Drug Administration Modernization Act of 1997 (the user fee provisions of this act are known as PDUFA II).

FDA's performance goals were further revised in conjunction with the enactment of PDUFA III, set forth in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Section 502 of PDUFA III states that user fees will be dedicated to expediting the drug development process and the process for the review of human drug applications in accordance with the new performance goals.

FDA's proposal is on display today at the Office of the Federal Register and online at

Comments, identified by a docket number, may be submitted until October 18, 2004, to the agency via the internet through the Federal e-Rulemaking Portal: or through the FDA Web Site:

These websites provide instructions for submitting comments. People may also submit comments by E-mail through, including the docket number in the subject line of the e-mail message, or by fax at 301-827-6870.

All comments received will be posted without change to They will also be available for review in person at the Division of Dockets Management, 5630 Fishers Lane, Room 1061, Rockville, Md. 20852.

Source: The Food and Drug Administration

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