The nuance here is that the FDA appears to have made a determination that the manufacturing process change was not substantial. They do have the authority to make such a determination. And then we end up arguing about the Chevron deference.
The nuance here is that the FDA appears to have made a determination that the manufacturing process change was not substantial. They do have the authority to make such a determination. And then we end up arguing about the Chevron deference.
The nuance here is that the FDA appears to have made a determination that the manufacturing process change was not substantial. They do have the authority to make such a determination. And then we end up arguing about the Chevron deference.