The Skeptical Enthusiast’s Guide to “AI at FDA”

by Steven 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…....

Non-Defense Discretionary Spending Threatened By Budget Reconciliation Shortfalls

by Steven 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...

A Dangerous Idea: Two Drug Manufacturing Pathways–One Regulated, One Not

by Steven Grossman | May 22, 2025 | Short Takes and Updates

Redefining “Special Medical Needs Compounding” to Permit Mass Production Threatens Consumer Protections Today, May 22, 2025, is the last day that mass compounded GLP-1 obesity medicines can be sold because FDA has declared the shortage over. Yet, some companies intend...

Finally, Some Encouraging News from FDA

by Steven Grossman | May 20, 2025 | Short Takes and Updates

The most important questions facing FDA and the stakeholder community are: After the lay-offs, RIFs, and voluntary departures, does the FDA have enough staff and expertise to fulfill the agency’s responsibilities?If there are tasks and obligations that will not...

If You Are Not Confused, Then You Are Not Paying Attention: FDA Edition

by Steven Grossman | May 15, 2025 | Short Takes and Updates

“Flooding the zone” has worked as a strategy for the Trump Administration, at least so far. We are all so busy reacting to the newest proposals that we don’t have time to address the previous week’s initiatives from the Administration. While I can’t seem to get ahead,...