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Bill to simplify commercialization of ACT proposed
Published: 2009-10-16 06:57:00
Updated: 2009-10-16 06:57:00
A lawmaker has proposed a bill to let an autologous cell therapy commercialize with Phase I clinical trial only, holding a promise to patients with rare or life-threatening diseases.
Under the proposed bill, a drug maker who intends to market ACT will get a product license with approval of Phase I pharmacology data only, while omitting other data submission related to Phase II and III trials...
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