The Food and Drug Administration has issued a draft guidance for the development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The draft guidance emphasizes the need to focus the label's adverse reactions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
- 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The draft guidance is available on FDA's website:
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.