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The Senate bill would replace the current OTC rulemaking procedures with an administrative order process, whereby through initiation by the agency or at the request of a requestor (i.e., any person or group of persons marketing, manufacturing, processing, or developing a drug), FDA could issue an administrative order determining whether there are conditions under which specific drugs, classes of such drugs, or combinations of such drugs are generally recognized as safe and effective

March 2007;75(5):683-688

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