What must drug applicants submit to the FDA to support a proposed expiration date and storage conditions?
Answer
Stability testing data.
The process for gaining FDA approval for a drug product necessitates rigorous scientific evidence supporting any claim regarding how long the product retains its characteristics under specified conditions. This evidence is formally provided through comprehensive stability testing. Drug applicants must supply the results of these controlled experiments, which verify that the drug maintains its required strength, quality, and purity over the proposed time frame. This submission forms the scientific justification upon which the regulatory body approves the necessary storage parameters and the corresponding expiration date printed on the final packaging.
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