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Targeted Safety Data Collection Needs International Agreement, Industry Tells FDA

 
• By Sue Sutter

FDA’s proposal to limit collection of certain safety data in late-stage and post-marketing clinical trials will only reduce the burden on sponsors, investigators and patients if drug regulators across the globe agree to the concept, pharmaceutical manufacturers say.

An FDA proposal to reduce the amount of safety data collected in some late-stage and post-marketing studies must be harmonized with the views of global regulators for it to be workable, pharmaceutical manufacturers said in comments on a recent draft guidance.

Given the multi-national composition of many clinical trials, the guidance’s provisions – which allow for limited or non-collection of certain...

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