2011-26297. Guidance for Industry on Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products-Content and Format; Availability

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 “Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format.” This guidance is intended to assist applicants and reviewers in drafting the “Warnings and Precautions, Contraindications, and Boxed Warning” sections of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format.

DATES:

Submit either electronic or written comments on Agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Cheryl Grandinetti, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3244, Silver Spring, MD 20993-0002, 301-796-3516; or

Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format.” The guidance provides recommendations on how to determine which adverse reactions are significant enough to warrant inclusion in the “Warnings And Precautions” section; how to decide what situations warrant a “Contraindication”; and when to include a “Boxed Warning.” The guidance also provides recommendations on how to organize each section and what information to include when describing warnings and precautions, in situations when the use of the product is contraindicated, and in a boxed warning.

This guidance is one of a series of guidances FDA is developing, or has developed, to assist applicants and reviewers with the content and format of certain sections of the labeling for human prescription drug and biological products. In the Federal Register of January 24, 2006 (71 FR 3999), FDA issued final guidances on the content and format of the “Adverse Reactions” and “Clinical Studies” sections of labeling. In the Federal Register of October 19, 2009 (74 FR 53507), FDA issued a final guidance on determining established pharmacologic class for use in the highlights of prescribing information. In the Federal Register of March 23, 2010 (75 FR 13766), FDA issued a final guidance on the content and format of the “Dosage and Administration” section of labeling and in the Federal Register of March 3, 2009 (74 FR 9250), FDA issued a draft guidance on the content and format of the “Clinical Pharmacology” section of labeling. The new labeling requirements (final rule, January 24, 2006, 71 FR 3922) and these guidances are intended to make information in prescription drug labeling easier for health care practitioners to access, read, and use.

On January 18, 2006, FDA issued a draft of this guidance on the “Warnings and Precautions, Contraindications, and Boxed Warning” sections of the labeling to obtain public comment (71 FR 3998). FDA received a number of comments, most of which focused on clarifications and further illustrations of issues discussed in individual sections and subsections of the guidance. FDA reviewed all received comments carefully during the finalization of the guidance. Other than clarifying edits, no changes of significance were made to the final version of the guidance.

This 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 content and format of the “Warnings and Precautions, Contraindications, and Boxed Warning” sections of labeling for human prescription 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) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 201.57 and 201.56 have been approved under OMB control number 0910-0572.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm,, http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​default.htm or http://www.regulations.gov.

Dated: October 6, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.