03-25306. Guidance for Industry on Continuous Marketing Applications: Pilot 1-Reviewable Units for Fast Track Products Under the Prescription Drug User Fee Act of 1992

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Continuous Marketing Applications: Pilot 1—Reviewable Units for Fast Track Products Under PDUFA.” This is one in a series of guidance documents that FDA agreed to draft and implement in conjunction with the June 2002 reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA). Pilot 1 will enable certain applicants to receive early feedback on portions of their applications. Pilot 1 will also evaluate the benefits and costs of providing early feedback to applicants.

DATES:

Submit written or electronic comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of the guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office of Communications, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist either office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

John Jenkins, CDER (HFD-020), Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, 301-594-3937, or

Robert A. Yetter, CBER (HFM-25), Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Description of the Guidance

FDA is announcing the availability of a guidance for industry entitled “Continuous Marketing Applications: Pilot 1—Reviewable Units for Fast Track Products Under PDUFA.” In conjunction with the June 2002 reauthorization of PDUFA, FDA agreed to meet specific performance goals (PDUFA Goals). The PDUFA Goals include two pilot programs to explore the continuous marketing application (CMA) concept. The CMA concept builds on the current practice of interaction between FDA and applicants during drug development and application review and proposes opportunities for improvement.

In the Federal Register of June 17, 2003 (68 FR 35903), FDA announced the availability of a draft version of this guidance. FDA received a number of comments on the draft guidance. We have considered the comments carefully and have made some changes to address those comments. Among other things, we have revised the guidance to further describe the selection of marketing applications for inclusion in Pilot 1, clarify the content and submission process for reviewable units, and provide for public availability of additional information during the program.

Under the CMA pilot program, Pilot 1, applicants submitting new drug applications or biological licensing applications for products that have been designated as Fast Track drug or biological products (i.e., products intended to treat a serious and/or life-threatening disease for which there is an unmet medical need) may be eligible to submit portions of their marketing applications (reviewable units) in advance of the complete marketing application. FDA has agreed to complete reviews of reviewable units within a specified time and to provide early feedback for those presubmissions in the form of discipline review letters.

This guidance provides information on how the agency will implement Pilot 1. As described in the guidance, Pilot 1 is an exploratory program that will allow FDA to evaluate the added value, costs, and impact of early review and feedback on parts of applications (reviewable units) in advance of submission of the complete application.

This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on the implementation of the Pilot 1 program for reviewable units of certain Fast Track drug and biological products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the guidance at any time. Two copies of mailed comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet can obtain the guidance at either http://www.fda.gov/​cder/​guidance/​index.htm or http://www.fda.gov/​cber/​guidelines.htm.

Dated: September 29, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.