What experience have you had?
What experience have you had? How many INDs, 510ks, etc have you worked on? Because this does not line up with my experience at all. IME FDA is very anal about even the appearance of the conflict of interest, and loosey-goosey is the last descriptor you would ever want to use for any interaction with FDA. That being said, informal interactions where FDA talks you through regulatory options do happen for high priority / unmet need diseases, but there the “friendlies” are compartmentalized away from the those who review the applications. My guess is that the review will show that someone from FDA met with the company to facilitate the application because Alzheimer’s is a priority disease, but strict compartmentalization from the review process was maintained. If not, then someone is getting fired.
Posted by pfisherman on Jul 10, 2021, 5:01 PM
Tags
Related issues
- The biggest problem with MOND is that it was hand-crafted with additional parameters simply to fit the data.
- (My comment is about detached houses).
- The biggest problem with this is that I can't run my company's own internal benchmarks against this API, because they will be trained int...
- > steer Claude away from over-engineering parts of the system in response to hypothetical concerns.
- Why is there no comparison with FLUX 3 Image?
- > our Git monorepo was developing an annoying problem Sentences like this are so common from people using monorepos that I am convinced ...
Raise real-world problems, find people facing the same issue, and discuss solutions.3,000 issues0 comments
hackernews (Other)
The biggest problem with MOND is that it was hand-crafted with additional parameters simply to fit the data.
(My comment is about detached houses).
The biggest problem with this is that I can't run my company's own internal benchmarks against this API, because they will be trained int...
> steer Claude away from over-engineering parts of the system in response to hypothetical concerns.
Why is there no comparison with FLUX 3 Image?
> our Git monorepo was developing an annoying problem Sentences like this are so common from people using monorepos that I am convinced ...
Why is there no contact form?
The biggest problem with plugging a generator into an outlet is you need a double ended cord.
What experience have you had?
What experience have you had? How many INDs, 510ks, etc have you worked on? Because this does not line up with my experience at all. IME FDA is very anal about even the appearance of the conflict of interest, and loosey-goosey is the last descriptor you would ever want to use for any interaction with FDA. That being said, informal interactions where FDA talks you through regulatory options do happen for high priority / unmet need diseases, but there the “friendlies” are compartmentalized away from the those who review the applications. My guess is that the review will show that someone from FDA met with the company to facilitate the application because Alzheimer’s is a priority disease, but strict compartmentalization from the review process was maintained. If not, then someone is getting fired.
Comments (0)
No comments yet. Start the discussion.