This is a tough one. Love to hear folks’ perspective
‘Remember her as the badass she was.’ The first bit of the title caught my attention, as I expect that it was intended to do. I had a look. I like to stir the pot from time to time, this one delivered.
Expanded Access always seemed like a good idea to me, I mean if there are no other options, from where I sit, I might ask why not? I expect that was the thinking behind the passage of many states’ Right to Try legislation, and the federal law passed in May, 2018.
While that clears the deck from a legal perspective, as before, the final decision on who gets to try belongs to the drug sponsor. And as described in this article, it is a tough call.
I was at my first job at FDA in the mid 1990s when the Parklawn Building was seemingly surrounded by…
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