Pharmaceutical Outsourcing Q3 2023 - 2

FROM THE EDITOR
Editor's Message
They Let Me In - Again
I checked my Hotels.com account.
The last time I was at the FDA's White Oak campus in Silver Spring, Maryland was March 8th, 2020.
If you recall (or maybe you don't want to remember) this was about a week before the COVID-19 lockdown.
At the time there was much uncertainty - masks were recommended - but no one was really wearing them
yet. We didn't shake hands, or fist bump - but we elbow tapped (yes, that was a thing at the time).
In the halls of the FDA there was a palpable tension. So much was unknown. We were there to interview
Dr. Peter Marks for our Cell and Gene Therapy video documentary. Dr. Marks was very much involved with
the FDA's response to COVID-19 and I felt bad taking him away from that.
He was very generous with his time - and actually welcomed the opportunity to talk about something other than COVID-19 for a few minutes.
This time we were at the FDA interviewing another official - for another video documentary to be released later this year. But things
have changed.
While the atmosphere is returning to " normal " there are fewer people in the halls and less people in the cafeteria. I'm happy to report that their
security protocols haven't changed. I got that same feeling I had three years ago - guilty until proven innocent.
What also hasn't changed is the FDA's goal of getting new products to patients as quickly as possible. In fact, it appears that the pandemic
has accelerated the FDA's programs to work cooperatively with international agencies to make sure drugs get approved quickly and
simultaneously the world over.
It certainly is a daunting task - coordinating with numerous regulatory bodies to ensure products are delivered with the highest quality
and safety.
The FDA seems very much open to working collaboratively with companies and agencies bringing new products to market. And, at least to
me, is working hard to shed their image of being difficult to work with.
Also - if you go - their cafeteria makes good coffee.
Mike Auerbach
Editor In Chief
mauerbach@comparenetworks.com
Pharmaceutical Outsourcing | 2 | July/August/September 2023

Pharmaceutical Outsourcing Q3 2023

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