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Disclosure of the Dealings Between Drug Developing Companies and the FDA Under the Federal Securities Laws

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2002

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Disclosure of the Dealings Between Drug Developing Companies and the FDA Under the Federal Securities Laws (2002 Third Year Paper)

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Abstract

The purpose of this article is to highlight the main issues raised by the Food and Drug Administration’s (“FDAâ€) approval process relating to new drugs and the treatment of this process receives in the context of the Federal Securities Laws . The partial inspiration for this article has been the recent highly publicized case concerning ImClone Systems Incorporated – a case, which well exemplifies both the connection between the valuation of a biotech/medical company and the FDA’s approval process for new drugs, and also the huge effect of the approval process to the market’s valuation of the stock price.

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Food and Drug Law, FDA, securities, disclosure, approval, ImClone

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