by Steven A. Grossman | Jun 30, 2025 | Short Takes and Updates
There is very little support among stakeholders and FDA employees for the 2025 version of the FDA.[1] Some of us are discouraged. Some of us are trying hard to find the good in agency proposals and actions. Regardless of where any of us stand, all of us need to be...
by Steven A. Grossman | Jun 24, 2025 | Short Takes and Updates
This article builds upon my May 22 column, entitled A Dangerous Idea: Two Drug Manufacturing Pathways, One Regulated, One Not.[1][2]—-Recently Novo Nordisk dropped out of its arrangement with Hims and Hers because the latter continued to sell compounded GLP-1...
by Steven A. Grossman | Jun 16, 2025 | Short Takes and Updates
As children, we are taught that “sticks and stones will break my bones, but words will never hurt me.” That may have helped children develop resilience against verbal bullying, but it totally discounted the power of words. As adults, we know better. Words...
by Steven A. Grossman | Jun 10, 2025 | Short Takes and Updates
Elon Musk thought cutting government programs was about deficit reduction. When the “One Big Beautiful Bill” reconciliation legislation passed the House with a $3 trillion price tag, he realized he had been misled and reacted accordingly. His falling out with the...
by Steven A. Grossman | Jun 3, 2025 | Short Takes and Updates
I welcome Commissioner Makary’s embrace of AI[1] and applaud yesterday’s announcement of the next step in agency adoption of AI technology. [2]I wrote earlier that: “AI can help FDA make better regulatory decisions based on more refined and accurate information…....
by Steven A. Grossman | May 28, 2025 | Short Takes and Updates
“While discretionary spending is not part of the reconciliation process, some policymakers may point to savings from that category as “offsets” for other policies.”[1] FDA makes significant contributions to public health, public safety, scientific and technological...
