rachon schreef op 25 februari 2014 13:10:
PDUFA info request
Dear Mr. ***,
During the review process with the FDA questions and requests from the FDA
come on a regular basis. The replies to the FDA are called ³amendments to
the BLA" Towards the end of the review period the FDA classifies the
replies as minor or major , depending on the amount of new information
from the amendment that the FDA has to review. The last amendment that we
submitted was on 13 Feb and was quite bulky. The FDA responded by
classifying this as major and as it was too close to the internal FDA
deadline to deal with a major amendment, they took the step to extend
the review period with a standard three months extension of the review
period. This happens more often. That is all there is to it.
Trust this answer helps.
Kind regards / Met vriendelijke groet,