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

The purpose of this article is to highlight the main issues raised by the Food and Drug Administrationi?½s (i?½FDAi?½) 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 i?½ a case, which well exemplifies both the connection between the valuation of a biotech/medical company and the FDAi?½s approval process for new drugs, and also the huge effect of the approval process to the marketi?½s valuation of the stock price.