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September 2, 2010 Print E-mail
September 02, 2010 by Donald Riker, PhD   

Find the latest pharmaceutical manufacturing news on automation & control, supply chains, GMP, anticounterfeiting, and other pharma manufacturing news.

"The pain patch business is in a kind of regulatory limbo, says Riker. The FDA has issued no final ruling on its regulation, despite a petition by the Consumer Healthcare Products Association...if the FDA ultimately requires NDAs, "Hisamitsu has a big head start," Riker says. The foreign manufacturer has "played by the rules" while domestic manufacturers appear to have "placed their bets on the usual slowness of the FDA and are still playing the clock."

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