Guides
Plain-English explainers for the events in the tracker: what each one is, where the date comes from, and how to read the announcement when it lands. Each guide cites the primary rules and uses real rows from the tracker as examples.
The PDUFA target action date is the FDA's own deadline for deciding on a drug application. Here is where it comes from, how it moves, and why you only hear about it from the company.
Who sits on an FDA advisory committee, how the day runs, what the vote means and doesn't mean, and where to find the documents beforehand.
A Complete Response Letter is the FDA's "not yet" on a drug application. What it contains, the company's options, how resubmission clocks work, and how to read the announcement.
Endpoints, p-values, effect sizes, safety tables and the phrase "met its primary endpoint": a practical guide to reading the press release a company puts out when pivotal trial results land.
What each phase of clinical development is for, roughly how big the trials are, what the in-between labels like 1b, 2a and 2/3 mean, and what a readout at each stage can and can't tell you.
Why some products are filed as a New Drug Application and others as a Biologics License Application, who reviews each, what supplements and rolling submissions are, and why the difference matters after approval.
The FDA's expedited programmes are often lumped together, but they do different things at different stages. What each one is, what it changes about the timeline, and what it doesn't promise.
A step-by-step walkthrough of the method behind this site: finding the filing that announced a PDUFA date or readout window, reading it properly, and spotting the traps that catalyst calendars fall into.
Why almost every row on this site links to an 8-K exhibit, what the 6-K is for, when a press release has no filing behind it, and how the item numbers and "furnished vs filed" affect what you're reading.
Most biotech catalysts don't have a date, only a window the company guided to. Why that is, what the common phrases mean, how windows tighten or slip, and how this site handles them.
Plain-English definitions of the regulatory, clinical and SEC-filing terms used across the tracker and the guides, from AdComm to Type A meeting.
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