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发帖数: 25265 | 1 A Special Protocol Assessment (SPA) is a declaration from the Food and Drug
Administration that an uncompleted Phase III trial's design, clinical
endpoints, and statistical analyses are acceptable for FDA approval.
Three types of protocols related to PDUFA products are eligible for this
special protocol assessment under the PDUFA goals:[1]
1.animal carcinogenicity protocols,
2.final product stability protocols,
3.clinical protocols for phase 3 trials whose data will form the primary
basis for an efficacy claim if the trials had been the subject of discussion
at an end-of-phase 2/pre-phase 3 meeting with the review division, or in
some cases, if the division agrees to such a review because the division is
aware of the developmental context in which the protocol is being reviewed
and the questions are being answered.
The clinical protocols for phase 3 trials can relate to efficacy claims that
will be part of an original new drug application (NDA) or Biologic License
Application (BLA) or that will be part of an efficacy supplement to an
approved NDA or BLA.
FDA guidance for industry: special assessment protocol can be found here:
http://www.fda.gov/downloads/Drugs/Guidances/ucm080571.pdf |
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