Took a while to compare the two Branches- they have identical responsibilities, I wonder if we are being handled by Branch 1 rather than Monsieur Klinker's Branch 2.

I went digging because JB had been making Monsieur Klinker out to be infallible and that if Ryoncil was approved it would be akin to the greatest injustice ever perpetrated in the history of scientific endeavour. ( possibly I gave this a bit of colour)

F. Develops policies and procedures applicable to the review and evaluation of INDs, IDEs, 510Ks, HDEs, PMAs, BLAs, and products regulated by the Office in the absence of Center-level policies and procedures.

G. Performs consultative reviews of product information and data in BLAs, BLA amendments, INDs, IDEs, 510Ks, HDEs, and PMAs in response to request from other Center components.


I am presuming that the Type A with senior FDA leadership included either the Branch 1 or Branch 2 Chief.

BLA came off it's stop- who's desk allowed that?

Interesting times

“There is no such thing as absolute truth and absolute falsehood. The scientific mind should never recognise the perfect truth or the perfect falsehood of any supposed theory or observation. It should carefully weigh the chances of truth and error and grade each in its proper position along the line joining absolute truth and absolute error.”

― Henry Augustus Rowland



Reg