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Adverse Reaction Section Proposed
ROCKVILLE, MD-The Food and Drug Administration (FDA) issued a draft guidance regarding the creation of an adverse reactions section of labeling for human prescription drugs and biologics. The goal is to make labeling more consistent and helpful to prescribers and patients. By establishing a comprehensible format, the FDA hopes prescribers will be able to absorb the most critical drug safety information easily when reading the drug label. Format guidance divides the labeling into two subsections: an overview section that highlights the most serious, commonly occurring adverse reactions; and an in-depth section detailing adverse reaction data collected from clinical trials. The draft also suggests that the section be limited to information that can be helpful in treating, monitoring, and advising patients.
A copy of the draft guidance can be found on the FDA's website at www.fda.gov/cder/guidance/1888dft.htm. No action will be taken on the new section until after a 90-day comment period. After that time, the FDA will issue a final guidance on the matter.