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Hints on Preparing Successful Orphan Drug
Should the FDA Regulate NicotineContaining
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action advertising agency application authority Biologics Bristol-Myers Squibb cigarettes Cipollone clinical codified at 21 common law Cong Congress congressional consumer cosmetic court found decision determine dietary supplement Drug Products drug samples DSHEA effect enforcement FDA regulation FDA's FDCA federal Federal Food Final Monograph food additive Food and Drug gene therapy Guidelines health claims industry ingredients intended Internet issue jurisdiction legislation liability Lohr manufacturer Medical Device Amendments medical devices Medtronic ment nicotine nutrition labeling orphan drug patent term PDMA pharmaceutical Pink Sheet plaintiffs preempted preemption provision premarket approval prescription drug product liability promotion proposed protection reform regulatory requirements rulemaking rules safety scientific Silkwood smoking specific standards Stat statement statute statutory Supp supra note tion tobacco products tort claims trade United URAA warning