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Split Real Time Application Review (STAR) (from Catapult’s regulatory round-up for November 2024)

Under the Prescription Drug User Fee Act (PDUFA) VII Commitment, FDA is creating the STAR pilot program which aims to shorten the time from the date of complete submission to the action date, in order to allow earlier patient access to therapies that address an unmet medical need.

FDA will consider an application eligible for the STAR pilot program if each of the following criteria are met:

  1. Clinical evidence from adequate and well-controlled investigation(s) indicates that the drug may demonstrate substantial improvement on a clinically relevant endpoint(s) over available therapies.
  2. Breakthrough Therapy Designation (BTD) or Regenerative Medicine Advanced Therapy Designation (RMAT) is not required, but above criteria must be met.
  3. The application is for a drug intended to treat a serious condition with an unmet medical need.
  4. No aspect of the submission is likely to require a longer review time (e.g., requirement for new REMS, etc.)
  5. There is no chemistry, manufacturing, or control information that would require a foreign manufacturing site inspection (i.e., domestic site inspections may be allowed if it does not affect the expedited timeframe).

Please find further information here.

Published on the 3rd of december 2024. Read the entire Regulatory Round-up – November 2024 here.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (12 février 2025). Split Real Time Application Review (STAR) (from Catapult’s regulatory round-up for November 2024). ELSIBI. Consulté le 12 janvier 2026 à l’adresse https://doi.org/10.58079/13axp


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