FDA guidance tracking, mapped to your submission.

FDA guidance documents interpret how the agency expects requirements to be met — and they are revised often. A single cybersecurity or software guidance can supersede its predecessor more than once in a few years, and drafting against the wrong version is easy to do and hard to catch.

Beyond the FDA, teams filing globally have to track EMA, PMDA, and other authorities in parallel, each with its own evolving expectations. Manually monitoring these sources — and knowing which change actually affects your submission — is a job in itself.

REGARA maintains a daily-indexed guidance atlas and maps each document to the submission sections it governs, so when expectations shift, you know exactly what to revisit and why.

• Q
  What is FDA guidance tracking?

  FDA guidance tracking is the practice of monitoring the agency’s guidance documents — which interpret regulatory expectations — for new, revised, and superseded versions, and understanding which changes affect your submissions. REGARA automates this with a daily-indexed atlas mapped to your work.

• Q
  Why does using current guidance matter?

  Guidance is revised frequently, and drafting to a superseded version can introduce expectations the FDA no longer holds — or miss ones it now does. Referencing the current guidance keeps your submission defensible at the moment you file.

• Q
  Does REGARA track non-FDA authorities?

  Yes. REGARA indexes guidance from the FDA, EMA, PMDA, and other authorities, giving global programs a single current view instead of separately monitoring each source.

• Q
  How is guidance connected to my submission?

  REGARA maps each guidance document to the submission sections it governs. When a relevant guidance is issued or revised, the change surfaces on the exact sections it affects, with the delta explained.