Which is a NDA review designation?

• A. S = Standard; P = Priority
• B. S = Special; P = Preliminary
• C. S = Safety; P = Process
• D. S = Summary; P = Protocol

Answer: (A)

NDA review designations indicate the speed with which the FDA will review a new drug application. The two terms used are Standard and Priority, with Standard representing the normal review timeline and Priority indicating an expedited review because the drug offers a meaningful improvement. In test terms, S stands for Standard and P stands for Priority, so the pairing shown is the accurate representation of NDA review designations.

Other pairings do not reflect how the FDA designates NDA reviews. Special/Preliminary, Safety/Process, or Summary/Protocol aren’t recognized as NDA review designations. Note that there are other regulatory programs (like Breakthrough Therapy or Accelerated Approval) that influence development or approval speed, but they are distinct from the basic NDA review designation.