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FDA Reviewer: The review process for drug safety and efficacy:

The safety review has two distinct components: (1) identification and assessment of the significance of the adverse events reported in clinical trials (controlled or uncontrolled) and (2) evaluation of the adequacy of the applicant’s safety evaluation.

This approach that integrates safety findings across all studies and other clinical experience. Consideration of the safety findings in individual studies, without a thoughtful integration of the overall safety experience, is not adequate for a safety review.

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Regulation process

1) Serious adverse events that suggest, or could indicate significant problems with a drug– specifically, adverse reactions severe enough to prevent its use altogether, to limit its use, or require special risk management efforts;

2) The frequency of the common (usually nonserious) adverse events that are, or may be, causally related to the use of the drug;

3) The adequacy of the data available to support the safety analysis and to identify the limitations of those data. At a minimum, this includes assessments of whether the extent of exposure at relevant doses is adequate;

4) Unresolved safety concerns that will need attention before approval or that should be assessed in the postmarketing period, including such matters as the absence of data from high-risk populations or potential interactions;

5) Factors that predict the occurrence of adverse reactions, including patient-related factors (e.g., age, gender, ethnicity, race, target illness, abnormalities of renal or hepatic function, co-morbid illnesses, genetic characteristics, such as metabolic status, environment) and drug-related factors (e.g., dose, plasma level, duration of exposure, concomitant medication)

6) Identify where possible, ways to avoid adverse reactions (dosing, monitoring) and ways to manage them when they occur;

7) A comprehensive evaluation of risk information adequates to support a factual and sufficient summary of the risk information in labeling.

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