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T00-30                      Print Media:         301-827-6242
June 23, 2000               
                            Consumer Inquiries:  888-INFO-FDA

GUIDANCE FOR ADVERSE REACTIONS LABELING

The Food and Drug Administration has issued a draft guidance for the development of the adverse reactions section of labeling for human prescription drugs and biologics. The document, which was published in the Federal Register on June 21, 2000 is the first in a series of guidances for industry that are intended to make the labeling more consistent and helpful to prescribers and patients.

The draft guidance emphasizes the need to focus the label's adverse reactions section on drug safety information that is important to prescribing decisions, and to convey it in a format that is clear, easy to find, and consistent across different drugs and drug classes. The common format provided by the guidance divides the labeling into two subsections:

• an overview subsection that highlights the adverse reactions that are most serious, most commonly occurring, and most frequently resulting in clinical interventions; and
• a discussion subsection that deals in greater detail with the significance of adverse reaction data obtained from the clinical trials.

Although the guidance seeks to assist industry in bringing greater consistency to the content and format of the adverse reactions section of the labeling, agency recognizes the critical role of individual judgment in presenting the adverse reactions data. The guidance suggests that the adverse reactions section be limited to information that can be helpful in treating, monitoring and advising patients. Long and exhaustive lists of every reported adverse event, including those that are infrequent or minor, should be avoided.

The draft guidance is available on FDA's website:

• www.fda.gov/cder/guidance/1888dft.htm (HTML and PDF)
• www.fda.gov/cber/guidelines.htm (Text file and PDF)

It is not intended for implementation until FDA issues a final guidance following a 90-day comment period. Comments should be submitted to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

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