by Steven A. 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...
by Steven A. 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...
by Steven A. 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,...
by Steven A. Grossman | May 12, 2025 | Short Takes and Updates
I am tired of the continued defamation of FDA as an agency controlled by industry. That is not to say that FDA is perfect or that there have never been FDA-industry interactions that looked (and maybe were) bad. However, as a generalization….no, FDA is not...
by Steven A. Grossman | May 8, 2025 | Short Takes and Updates
The headline, “Dr. Prasad to succeed Peter Marks as CBER director,” spread like wildfire Tuesday night after Endpoints News broke the story. Reactions ranged from “Omigod, he’ll destroy the industry and the hopes of patients” to “no big deal, staff do the product...
by Steven A. Grossman | May 2, 2025 | Short Takes and Updates
After 50 years in Washington, I have no expectation of being told the truth by government officials—elected or appointed. I like to think I have seen it all—shading the truth, burying the truth, plausibly deniable truth, and sometimes things entirely made up and...
