Evaluation of US Package Inserts Following the Physician Labeling Rule - Sponsored Whitepaper

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FDA issued a guidance document entitled “Adverse Reactions Section Labeling for Human Prescription Drug and Biological Products – Content and Format” in January 2006. The guidance is intended to assist both applicants and reviewers draft the Adverse Reactions section of the prescribing information in the new format specified by the labeling rule finalized in January 2006 and effective June 2006. The guidance document makes several general recommendations: FDA reviewers and applicants should assess such factors as seriousness, severity, frequency and strength of causal association in determining which adverse reactions to include in the Adverse Reactions section and in characterizing those reactions. The Adverse Reactions section should only include information that would be useful to health care practitioners making treatment decisions and monitoring and advising patients. Exhaustive lists of every reported adverse event, including those that are infrequent and minor, commonly observed in the absence of drug therapy or not plausibly related to drug therapy, should be avoided. Adverse reactions from clinical trials and spontaneous reports should be presented in separate lists.

The Adverse Reactions section should identify the most commonly occurring adverse reactions1; for example, all adverse reactions occurring at a rate of 10% or greater in the treatment group compared to the control group, and at a rate at least twice the placebo rate. The chosen frequency should be appropriate to the size of safety database.

1 Note: FDA continues to define Adverse Reaction as an undesirable effect reasonably associated with the use of a drug; that is, a reasonable causal association has been determined.

Evaluation of US Package Inserts A BioSoteria, Inc. White Paper Following the Physician Labeling Rule - 1 - March 2010

A list of adverse reactions occurring below this threshold should be presented for those adverse events where there is evidence of a causal relationship between the drug and the event. A causal association may be based upon one or more of the following:
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