What Is an FDA Calendar and Why Do Investors and Operators Watch It?
An FDA calendar is a working schedule of regulatory events that matter to biotech companies and the people following them. It usually includes PDUFA dates, AdCom meetings, NDA and BLA filings, approval decisions, Complete Response Letters, label expansions, and sometimes major manufacturing or inspection-related milestones that affect timing. The reason people care is simple: these are the dates when the story can change.