I work for a huge company and everything we do or
Post# of 5066
Posted On: 09/27/2013 3:03:13 PM
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I work for a huge company and everything we do or officially tell a customer has to go through the Legal department. Legal may ask us to define more processes or steps for a certain task. They may ask us to follow a certain guideline or template before communicating with the customer.
I believe the FDA would be the same. It would have to pass a certain number of groups before it gets approval. Before approval, I would think they would have a legal department that would look over the submittal and may have requested more details surrounding the studies or want to see more documentation. If not legal, maybe a scientist who wants to make sure everything is solid before initiating trials to be done on humans.
In my mind, there is nothing wrong with the FDA asking for another study to be done. They may have asked for a larger control group or use a certain process at a certain step. The FDA asking for another study shows me that they are interested in the science and want to know more.
Just my two cents.
I believe the FDA would be the same. It would have to pass a certain number of groups before it gets approval. Before approval, I would think they would have a legal department that would look over the submittal and may have requested more details surrounding the studies or want to see more documentation. If not legal, maybe a scientist who wants to make sure everything is solid before initiating trials to be done on humans.
In my mind, there is nothing wrong with the FDA asking for another study to be done. They may have asked for a larger control group or use a certain process at a certain step. The FDA asking for another study shows me that they are interested in the science and want to know more.
Just my two cents.
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