FDA Drug Approval Pathway
From IND through NDA / BLA to post-marketing surveillance.
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flowchart LR
Pre["Preclinical<br/>(in vitro + animal)"] --> IND[IND submission]
IND --> P1[Phase I\nsafety]
P1 --> P2[Phase II\nefficacy signal]
P2 --> P3[Phase III\npivotal RCT]
P3 --> NDA[NDA / BLA submission]
NDA --> Rev{FDA review}
Rev -- approved --> Mkt[Market launch]
Rev -- CRL --> Resub[Address CRL → resubmit]
Resub --> Rev
Mkt --> P4[Phase IV\npost-marketing surveillance]
P4 -.->|AE signal| Label[Label updates / REMS]