Hutt, Peter BartonHeinonen, Mikko2012-06-072002Disclosure of the Dealings Between Drug Developing Companies and the FDA Under the Federal Securities Laws (2002 Third Year Paper)http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852181The 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.en-USFood and Drug LawFDAsecuritiesdisclosureapprovalImClonePaper (for course/seminar/workshop)2012-06-07