#5SmartReads - December 2, 2020
On Georgia, the Royal Family, and the war for Christmas (movies)
Scoop: FDA chief called to West Wing (Axios)
I want to share one of my first days working in pharma.
I spent my first 3 months onsite at one of our partner companies, and on my first day I helped put together and package an FDA follow-up submission for one of our jointly developed products.
And I mean that literally.
Probably a hundred thousand pages were printed, hole punched, placed in binders, checked and checked and checked again, and placed into boxes. I was in the office with the rest of the team until 1 am, packing each of the binder in the correct box.
And this was a follow-up submission.
An FDA submission is reviewed by teams of experts in clinical and nonclinical development, formulation and chemistry, and manufacturing. It takes a lot of time to review every detail to ensure a therapeutic is safe and effective, especially when it’s a vaccine for a deadly virus that’s killed millions across the world and infected over 63 million.
I hope you consider this context as you read this ar…
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