FDA Special Protocol Assessment
Encyclopedia
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:
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.
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
that an uncompleted Phase III trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
's design, clinical endpoints, and statistical analyses
Statistics
Statistics is the study of the collection, organization, analysis, and interpretation of data. It deals with all aspects of this, including the planning of data collection in terms of the design of surveys and experiments....
are acceptable for FDA approval.
Three types of protocols related to PDUFA products are eligible for this special protocol assessment under the PDUFA goals:
- animal carcinogenicity protocols,
- final product stability protocols,
- 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
New drug application
The New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing...
(NDA) or Biologic License Application
Biologic License Application
As defined by the US FDA, a Biologic License Application is: Biological products are approved for marketing under the provisions of the Public Health Service Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product...
(BLA) or that will be part of an efficacy supplement to an approved NDA or BLA.