00-28776. Draft Guidance for Industry on Cancer Drug and Biological Products-Clinical Data in Marketing Applications; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Cancer Drug and Biological Products—Clinical Data in Marketing Applications.” The draft guidance document provides recommendations for sponsors designing clinical trials to demonstrate the safety and efficacy of cancer treatments on the collection of data that may be submitted to support marketing claims in new drug applications (NDA's), biologics license applications (BLA's), or applications for supplemental indications.

DATES:

Submit written comments on the draft guidance by January 8, 2001. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Drug Information Branch (HFD-210), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The document may also be obtained by fax by calling the FAX Information System at 1-888-CBER-FAX or 301-827-3844. See the Supplementary Information section for electronic access to the draft guidance.

Submit written comments on the document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Grant A. Williams, Center for Drug Evaluation and Research (HFD-150), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5740, or Patricia Keegan, Center for Biologics Evaluation and Research (HFM-573), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-5093.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Guidance for Industry: Cancer Drug and Biological Products—Clinical Data in Marketing Applications.” This draft guidance provides general principles for data collection and submission for sponsors of investigational new drug applications, NDA's, BLA's, or applications for supplemental indications. It is intended to enable sponsors to more effectively create plans to record and report the data from controlled trials that form the clinical basis for approval of anticancer drug and biological products.

This draft level 1 guidance is being issued consistent with FDA's good guidance practices (65 FR 56468, September 19, 2000). The draft guidance represents the agency's current thinking on clinical data in marketing applications for cancer drug or biologic 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 written comments on the draft guidance to the Dockets Management Branch (address above). Two copies of any 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 draft guidance and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

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

Dated: October 30, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.