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- Title
Indian Regulatory Update: September-November 2013.
- Authors
Suvarnapathaki, Kedar
- Abstract
The article offers updates in the Central Drugs Standard Control Organization's (CDSCO) regulatory requirements regarding conduct of clinical trials in India for September-November 2013. The organization has issued formula to determine the quantum of compensation in the cases of serious adverse events of deaths occurring during the clinical trials. The CDSCO also has issued an office order requiring investigators to submit copy of clinical trial agreement along with clinical trial application.
- Subjects
INDIA; MEDICAL research; GOVERNMENT regulation; CLINICAL trials; CLINICAL drug trials; ADVERSE health care events; CENTRAL Drugs Standard Control Organization
- Publication
Perspectives in Clinical Research, 2014, Vol 5, Issue 1, p45
- ISSN
2229-3485
- Publication type
Article
- DOI
10.4103/2229-3485.124575