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Law.com - Business Battle Over Generic Drugs Heats Up With Stalling Tactics
Law.com - Business Battle Over Generic Drugs Heats Up With Stalling Tactics
立達
收藏於 2007/07/09
引述 :『One controversial means of delaying low-priced generics entering the market in recent years has been use of the regulatory process known as "citizen petitions" brought before the Food and Drug Administration, which temporarily halts generic approvals while the FDA investigates safety challenges raised in the petitions. Of 45 petitions seeking review between 2003 and mid-2005, the FDA had ruled on 21, denying 20 of them, according to the FDA. No "11th-hour" petitions, or those filed on the eve of a generics' approval, have been approved. "Citizen petitions are filed infrequently," said Scott Lassman, senior assistant general counsel for Pharmaceutical Research and Manufacturers of America (PhRMA). He noted that of 104 name products, just 12 petitions were filed, according to a 2002 Federal Trade Commission study. The evidence that they are filed purely to block generics is "very scant," he said.』
from
http://www.law.com/jsp/arti...
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