by Steven A. Grossman | Aug 12, 2025 | Short Takes and Updates
FDA Matters doesn’t cover the news….we provide analysis of what’s behind the newsThe goal of FDA Matters is to analyze FDA policy and regulatory issues and advocate for a more effective, more efficient, and fairer FDA. In support of the agency, I...
by Steven A. Grossman | Aug 8, 2025 | Short Takes and Updates
FDA Matters doesn’t cover the news….we provide analysis of what’s behind the newsThis week: August in DC—No Longer SlowThe Difficult Path to An FDA that Is “Just Right,” Neither Too Hard Nor Too Soft Former FDA Commissioner David Kessler...
by Steven A. Grossman | Jul 31, 2025 | Short Takes and Updates
Every day, we are failing patients with chronic progressive neurological, neuromuscular, and genetic diseases. The brouhaha about Sarepta and Elevidys[1][2] is just a reminder that we are not systematically addressing the common plight of these patients: 1/ their...
by Steven A. Grossman | Jul 25, 2025 | Short Takes and Updates
FDA Matters doesn’t cover the news….we provide analysis of what’s behind the newsThis week: Familiarity Breeds Respect Imminent Danger Regarding Food Priorities New CDER Leadership Re-Exploring Reconciliation Cuts’ Impact on FDA Consumer Protection...
by Steven A. Grossman | Jul 18, 2025 | Short Takes and Updates
A little under half of the FDA’s roughly $7 billion budget is funded by user fees. Tobacco user fees pay for the entire tobacco program, while medical product user fees pay for between 20% and 70% of most medical programs.Food programs are, effectively, “all taxpayer...
by Steven A. Grossman | Jul 8, 2025 | Short Takes and Updates
“The One Big Beautiful Bill Act” (aka OBBBA) was signed into law on July 4, 2025. The immediate and long-term consequences of this bill are the most important story to write about today. Other topics can wait. ———————Whether...
