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Home » FIRMS CLASH OVER MARKETED UNAPPROVED DRUG GUIDANCE
FIRMS CLASH OVER MARKETED UNAPPROVED DRUG GUIDANCE
February 17, 2004
The FDA’s efforts to close a loophole in enforcement actions on marketed unapproved drugs have pitted one drugmaker that argues the loophole punishes firms that apply for a new drug application (NDA) against another company that says closing the loophole will limit competition and drive up prices for the drugs.