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Sponsors weighing India usually start with “it’s cheaper” — which is true and almost useless as a reason to go. The real savings come from a few specific places: site and operational economics, faster enrollment in deeper patient populations, and an operating model with fewer handoffs. Where the savings do not come from — and

There is no FDA “approval letter” for an Investigational New Drug application. Under 21 CFR 312.40(b)(1), your IND goes into effect 30 days after the FDA receives it — unless the Agency places it on clinical hold. Silence on Day 30 is the green light. First-time sponsors who sit idle waiting for an approval that never arrives lose weeks