What is FDAs policy regarding patient populations from India? What is acceptable regarding a more homogenous population that may not fully reflect the US?
FDA has a policy on inclusion of foreign patient data for registration of drugs for marketing in USA. There is no negative or positive bias towards India. A white paper on the subject is on our website. Numerous audits of global sponsors and US FDA in India are a testimony to the level of quality. Data from clinical studies in India have been successfully filed with international regulatory agencies. The overall impression is that the data quality in India is usually excellent.