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Rethinking Phase IV: Congress Wants to Get Tough on Post-Marketing Requirements, but FDA May Soften the Blow

 
• By Kate Rawson

Congress is ready to grant FDA more authority over Phase IV studies-over the objections of both agency officials and drug sponsors. But if FDA is right, improvements to the designs of post-marketing studies may help reduce the impact on industry.

By Kate Rawson

When it comes to the debate over post-marketing drug safety, the pharmaceutical industry better start preparing for at least one inevitability: that Congress will grant the Food & Drug Administration more muscle to force drug sponsors to complete their Phase IV study commitments

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