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OTC Drug Irradiation Rule Exposed As Unnecessary In FDA Regulatory Review

This article was originally published in The Pink Sheet & The Rose Sheet

Executive Summary

US FDA proposes to repeal regulation that, since 1955, has required an NDA or ANDA for any drug product sterilized by irradiation, including drugs that otherwise would be marketed under an OTC monograph. It notes the Trump administration's order that federal agencies identify and potentially eliminate any unnecessary rules and regulations.

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