What a joy to attend this premier regulatory affairs event in person, under the blue skies and 100F heat (!) in Phoenix, Arizona. This first face-to-face assembly in three years was jump started by a video message from the United States FDA Commissioner, Robert M. Califf, M.D.

Dr Califf discussed the role the FDA plays every single day in ensuring that
only safe and effective medical therapies are available to patients, care
givers, and clinicians. He spoke with great passion regarding the solemn responsibility
to protect the American public by the objective evaluation of scientific evidence.
He called upon the conference attendees for help: to please incorporate an obligation
for stopping the flow of misinformation detrimental to the health of the nation
and responsible for an insidious decline of public confidence in the Agency.

The Commissioner is correct that as regulatory affairs professionals we have
a duty of care to not only ensure the data submitted to the FDA for review is compliant but to also support the bipartisan conveyance of scientifically accurate information.

“Your best ideas on how to improve the system could have a significant
impact as we think about crafting regulatory policy in the face of opportunity
and risk.”

Let us use this time together as an opportunity to work towards
positive solutions for the benefit of the health authorities, industry,
healthcare professionals and of course our patients.

K Young

KimYoung@instem.com

Photo: Photo by Jacob Morrison on Unsplash