This page lists 47 Complete Response Letters covering January 2025 to June 2026. A Complete Response Letter means the FDA declined to approve the application as submitted, and it does not by itself mean the drug is rejected for good.
A Complete Response Letter (CRL) is the FDA telling a company its application cannot be approved in its present form and what must be resolved first. It is not a final rejection: companies routinely address the deficiencies and resubmit.
The FDA's transparency dataset holds 458 Complete Response Letters, from 2002 through 2026, published as the agency's own redacted letters.
Many do: 309 of the 458 published letters belong to applications the FDA later approved. That count is not an approval rate -- the FDA's first transparency releases were letters for products it had since approved, and most recent letters belong to resubmissions still under way, so the published set over-represents happy endings by construction.
Yes. 83 applications in the FDA's published set received more than one letter across successive review cycles.