Replies to post #107845 on Biotech Values

[go seek]

that was my understanding also...

that the FDA does not pronounce in bits and pieces...

[akasidney86]

Zipjet: yes, you got it right. I doubt that the FDA would verbally parse their view of how an applicants documents are proceeding... what's been checked and what hasn't. I'd be very interested in opinions from people who have actually sat in those chairs in those meetings regarding the probable veracity of his statement.

[HattieTheWitch]

IF you mean, that you do not think FDA is going to tell an applicant that "yes you have established sameness" then I agree with that. It offers too much legal risk to go making pronouncements before the final decision. Clerks do not need that.

(my emphasis above)

Yes, but remember, TEVA said they spoke to management!

So there! >rolls eyes<