Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Guidance for Industry; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.” This guidance is one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and form at of labeling for human prescription drug and biological products. The guidance describes the recommended information to include in the CLINICAL PHARMACOLOGY section of labeling that pertains to the safe and effective use of human prescription drug and biological products. This guidance finalizes the 2014 revised draft guidance entitled “Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format.”

DATES:

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

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2009-D-0095 for “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format; Guidance for Industry; Availability.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 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.

FOR FURTHER INFORMATION CONTACT:

Joseph Grillo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3177, Silver Spring, MD 20993-0002, 301-796-5008; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 24, 2006 (71 FR 3922), FDA published a final rule entitled “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products” to revise the Agency's previous regulations on labeling (effective June 30, 2006). The final rule, commonly referred to as the Physician Labeling Rule (PLR), is designed to make information in prescription drug labeling easier for health care practitioners to access, read, and use, thereby increasing the extent to which health care providers rely on labeling for prescribing decisions.

In the Federal Register of March 3, 2009 (74 FR 9250), FDA announced the availability of a draft guidance on the format and content of the CLINICAL PHARMACOLOGY section of labeling. After considering received comments on the 2009 draft guidance, the Agency announced the availability of a revised draft guidance entitled “Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format” in the Federal Register of August 14, 2014 (79 FR 47650). After carefully reviewing received comments on the 2014 revised draft guidance and in light of the Agency's increased regulatory experience implementing the PLR and FDA's labeling and communication initiatives to ensure consistency and clarity, FDA has finalized the guidance.

II. Guidance

FDA is announcing the availability of a guidance for industry entitled “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format” as one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and format of labeling for human prescription drug and biological products. This guidance provides clarity on the information that should be included in section 12 CLINICAL PHARMACOLOGY of the prescription drug labeling under the PLR (21 CFR 201.57(c)(13)) and provides guidance on the inclusion of clinical recommendations based on clinical pharmacology findings in other sections of the labeling. The guidance is also intended to ensure consistency, as appropriate, in labeling of the CLINICAL PHARMACOLOGY section for all prescription drug products approved by FDA.

This guidance provides a general framework and set of recommendations that should be adapted to specific drugs and their conditions of use. Not all of the information identified in this guidance for inclusion in the CLINICAL PHARMACOLOGY section of product labeling will be applicable for every drug. For the purposes of this notice, all references to drugs include both human drugs and biological products unless otherwise specified.

The guidance outlines the use of subsections, headings, and subheadings to provide organization for the CLINCAL PHARMACOLOGY section in labeling. The guidance also emphasizes the importance of providing variability measures related to pharmacokinetic measures and parameters, pharmacodynamic measures, and other clinical pharmacology study results.

In addition to clarifications and edits throughout the guidance on various subsections of section 12, some notable changes from the revised draft guidance include:

• Addressing whether applicants are expected to revise current approved labeling if reserved sections 12.4 and 12.5 have already been used for other topics, and
• Providing revised recommendations on the inclusion of pregnancy and lactation information to be consistent with recommendations in FDA's “Pregnancy and Lactation Labeling Rule” ( https://www.federalregister.gov/documents/2014/12/04/2014-28241/content-and-format-of-labeling-for-human-prescription-drug-and-biological-products-requirements-for ) (December 2014) and draft guidance for industry entitled “Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products—Content and Format” ( http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm425398.pdf ) (December 2014).

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on inclusion of clinical pharmacology information in section 12 CLINICAL PHARMACOLOGY of product labeling. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirement of the applicable statutes and regulations.

III. The Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information that 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 201.56 and 201.57 have been approved under OMB control number 0910-0572; the collections of information related to pharmacogenomic data have been approved under OMB control number 0910-0557.

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/Guidances/default.htm,, or https://www.regulations.gov.