www.fdanews.com/articles/149356-clarity-sought-on-india-rsquo-s-proposed-formula-for-trial-injury-death-compensation
Clarity Sought on India’s Proposed Formula for Trial Injury, Death Compensation
September 11, 2012
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.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor