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FDAnews Device Daily Bulletin
Sept. 12, 2012 | Vol. 9 No. 179
Clarity Sought on India’s Proposed Formula for Trial Injury, Death Compensation
A newly released draft guideline on clinical trial death and injury compensation in India has clinical researchers concerned about how the basis for claims will be decided and payments formulated. In particular, the Association of Clinical Research Organizations wants India’s Central Drugs Standard Control Organization to clarify the role “risk factors” will play in setting compensation, spokesman John Lewis said.
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