Monday, March 2, 2009

Industry: "Regulatory Incentives languish" for safety and efficacy

The gold standard in the regulated product industry, The Gold Sheet (Vol 43, No 1) has some advice for Regulatory and Quality staff. (RAQA are those staffers who told Peanut Corp of America that it would be illegal and dangerous to sell deadly contaminated peanut butter. ) Last month's Gold Sheet says death and jail is not enough to stop criminal profiteers - RAQA now has to show how complying with the law saves money. Why? because "regulatory incentives languish."

That means for the last 8 years, FDA has not been allowed to do its job. And regulated companies know it.

"FDA officials encourage industry to concentrate on the business benefits of [Quality by Design or] QbD. [Controlling manufacturing or] CMC pilot [program]s raised questions about cost effectiveness."

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