The importance of getting a SPA is somewhat two fo
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Posted On: 03/16/2017 6:01:09 AM
The importance of getting a SPA is somewhat two fold. The company goes back and forth with the FDA to determine hopefully the right trial design for the phase 3 trial. On one hand CTIX gets the guidance that helps create the best path for success. On the other hand, if there are disagreements and the company decides not to take the guidance received, it may red flag the trial when the company submits for approval. If the drug works and they can prove it, the FDA may still send the company a warning letter to complete the portion the trial they decided not to use the guidance for. I forget the acronym for the warning letter. IMO
I just did a quick search...
Looks like this is an older version for SPA's
https://www.fda.gov/downloads/Drugs/Guidances/ucm080571.pdf
Wikpedia puts it simple enough...
https://en.wikipedia.org/wiki/FDA_Special_Pro...Assessment
A Special Protocol Assessment (SPA) is an advanced 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. The purpose of a SPA is to allow a company to run or initiate a clinical trial of an experimental drug without fear that the FDA will object to the trial design itself, in the event that the company subsequently applies for product 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.
I just did a quick search...
Looks like this is an older version for SPA's
https://www.fda.gov/downloads/Drugs/Guidances/ucm080571.pdf
Wikpedia puts it simple enough...
https://en.wikipedia.org/wiki/FDA_Special_Pro...Assessment
A Special Protocol Assessment (SPA) is an advanced 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. The purpose of a SPA is to allow a company to run or initiate a clinical trial of an experimental drug without fear that the FDA will object to the trial design itself, in the event that the company subsequently applies for product 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.
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