OSP file formats are added to the FDA's white list of file formats for electronic submissions.

[Yuri05]

The following OSP file formats are included:

• .pksim5 (PK-Sim project file)
• .mbp3 (MoBi project file)
• .pkml (OSP model exchange format)
• .json (PK-Sim project snapshots file)

S. Specification for Transmitting Electronic Submissions using eCTD Backbone Specifications (fda.gov) for details.