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CERTs Look to Re-Assert Larger Role in Post-Marketing Surveillance

 
• By Cole Werble

There is growing pressure on FDA and Congress to create public-private partnerships for enhanced postmarketing surveillance. The Agency for Healthcare Research and Quality already runs an existing network of academic centers that could fit the bill nicely.

Born out of an earlier revision of the Prescription Drug User Fee program in 1997, the CERTs—an eleven-member network of academic centers—appear well-positioned to gain an expanded role in postmarketing drug surveillance as a result of the ongoing PDUFA IV legislative negotiations.

The Centers for Education & Research on Therapeutics were established by the 1997 PDUFA II user fee legislation as extramural...

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