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E-Ferol follow-up

Executive Summary

In May 14 and 21 letters to FDA Com.-designate Young, Rep. Weiss (D-NY) asks FDA to identify "all 'new drugs' currently on the market which are not the subject of an approved" NDA or ANDA. Agency is to note date of initial marketing, distributors and mfrs., whether the drug is listed in the 1984 PDR, adverse reactions associated with its use and "the specific legal basis for permitting its continued marketing." Weiss also asks for "an explanation of FDA's regulatory requirements for reporting serious adverse effects associated with the use of the above-listed drugs".

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