Q&A Monday
This week’s Q&A Monday features these questions:
Did your column on MAHA intend to deliver a specific message to journalists and lead advocacy groups?
What is the most critical FDA issue in September?
What are some FDA issues that are simmering and will eventually surface?
Do you have suggestions for how I (and others like me) can take meaningful action or contribute to defending FDA, NIH, and CDC?
This week’s Q&A Monday features these questions:
Why has CDRH seemed uniquely untouched by this year’s upheaval at the FDA?
How does the WSJ editorial on drug approvals (here) relate to your late July article (here) calling for a National Agenda for Advancing Therapies for Chronic Progressive Diseases?
This week’s Q&A Monday features these questions:
Were you surprised by Dr. Prasad’s return to the agency?
How important is Dr. Kessler’s citizen’s petition and why do you think it moves the needle on the ultra-processed foods debate?
This week’s Q&A Monday features these questions:
What is FDA’s most pressing top-down need over the next few months?
Does USDA’s plans to move more staff to regional centers have any consequences for FDA?
Why did you choose to write about the need for better understanding and tools to evaluate chronic progressive diseases that are severely disabling or fatal?
This week’s Q&A Monday features these questions:
Is there a “revolving door” issue with Dr. Tidmarsh’s appointment as head of CDER?
Why is the Administration so apparently indifferent to the need for national investment to avoid falling behind China in the life sciences?
What is an important story that is not being widely discussed? (FDA’s headcount)
This week’s Q&A Monday features these questions:
What do you think of this week’s FDA panel on HRT therapy for menopausal women?
Is there any current issue that you feel is not getting the media attention it deserves?
What are standards of identity--why do we have them, why is FDA withdrawing some now?
This week’s Q&A Monday features these questions:
What is the farthest reaching, most consequential idea that you have advanced in FDA Matters?
What concept has been the most useful in explaining FDA during H1/2025?
A subscriber asked: your June 30 column, “All of Us Need to Be Rooting for FDA” (here) is an interesting take. Are you hearing a lot of stakeholders rooting for FDA failure?
This week’s Q&A Monday features these questions:
Do the efforts to dramatically shorten the approval process risk a thalidomide-type situation with no place for a Frances Kelsey to express concerns?
What is the starting point of the next round of negotiations on medical products user fees?
With regard to the new National Priorities Voucher initiative (NPV), you liked some aspects but “worry about diluting the focus on unmet medical needs.” Why does this concern you?
There was one FDA Matters column this week. Alice, Humpty Dumpty and the New Administration, in which I explored the meaning of radical transparency, gold-standard science, and ultra-processed foods.
I also posted a comment (here) on the new National Priorities Voucher (NPV) initiative at FDA. When we have more details, I will probably produce an entire column about it.