“A Dangerous Idea” Revisited — FDA Matters
Recently Novo Nordisk dropped out of its arrangement with Hims and Hers because the latter continued to sell compounded GLP-1 weight-loss products that are no longer legal (except in extremely limited...
There cannot be one set of rules for GLP-1compounding and another set of rules for other drug products.
As a result, the narrow exceptions that compounders want to expand would cross critical boundaries that FDA needs to preserve.
www.fdamatters.com/fdamatters/a...
#FDA #FDAMatters #compounding
25.06.2025 12:34 — 👍 0 🔁 0 💬 0 📌 0
Finally, Some Encouraging News from FDA — FDA Matters
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...
The most important questions facing FDA are about whether it can carry out its responsibilities. It’s too soon to know. Meantime, we are monitoring the situation and can report some encouraging signs of progress.
www.fdamatters.com/fdamatters/f...
#FDA #FDAMatters #FDAMakary #FDArehiring
20.05.2025 15:09 — 👍 0 🔁 0 💬 0 📌 0
Truth-Telling: FDA User Fee Edition — FDA Matters
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, plaus...
Once Commissioner Makary knows better what he can and cannot do, he needs to forthrightly address the shorter term. It is not pocket change: medical products companies have a $5 billion financial commitment to FDA for activities in FY 26 and FY27
www.fdamatters.com
#fda #FDAmatters #FDAuserfees
02.05.2025 17:07 — 👍 0 🔁 1 💬 0 📌 0
The American People in the Hands of an Indifferent Government — FDA Matters
The American People in the Hands of an Indifferent Government
FDA Matters: Downsizing doesn’t require indifference to human needs
www.fdamatters.com/fdamatters/t...
#FDA #FDAMatters #TheGrossmanFDAReport #Downsizing #Congress #DOGE
29.04.2025 20:33 — 👍 0 🔁 0 💬 0 📌 0
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
The latest from FDAMatters — The Grossman FDA Report:
Chesterton’s Fence: The Meaning of Deregulation & Other Thoughts About FDA
Read it here: www.fdamatters.com
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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #rif #userfees #deregulation #cspi #politico
11.04.2025 17:55 — 👍 0 🔁 0 💬 0 📌 0
RIF’s at FDA are random and arbitrary and that tells us a lot about what the Administration intends. We need to start focusing on Commissioner Makary immediate challenges: assessing what FDA can and cannot do with remaining staff and restarting the engine of production.
#FDA #FDAMatters
02.04.2025 17:18 — 👍 0 🔁 0 💬 0 📌 0
You are Entitled to Your Own Opinions, But Not to Your Own Facts — FDA Matters
If things went really bad at FDA, who would still be there at the end—caring enough about the agency and public health to keep fighting? My answer would be Dr. Peter Marks. I know you would agre...
FDA is immeasurably worse for Dr. Marks’s departure, as are the American people. A very bad week for FDA. I see two pressing needs…..
Read “You are Entitled to Your Own Opinions, But Not to Your Own Facts.” www.fdamatters.com
#FDA #FDAmatters #FDArif #PeterMarks #TheGrossmanFDAReport #DrMarks
29.03.2025 19:23 — 👍 0 🔁 0 💬 0 📌 0
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
Steven answers questions about the FDA RIF:
Relative to the FDA workforce, how big is the RIF?
Will the RIF exemption be “reviewer” or “reviewer teams,” “inspectors” or “inspector teams?”
Will so-called “user fee employees” be protected from the RIF?
and more on www.fdamatters.com today!
28.03.2025 16:55 — 👍 0 🔁 0 💬 0 📌 0
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
The topic: government downsizing in the 1990’s and now. Steven takes an historical view of the political dynamics of each and addresses the larger question of how much government Americans want. www.fdamatters.com
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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #federalworkers #govtdownsize
25.03.2025 21:24 — 👍 0 🔁 0 💬 0 📌 0
This 45-minute webinar will bring together medical and regulatory experts to discuss the implications of compounded obesity drugs, including potential risks, regulatory challenges, and patient safety ...
This 45-minute webinar will bring together medical and regulatory experts to discuss the implications of compounded obesity drugs, including potential risks, regulatory challenges, and patient safety ...
Join The Obesity Society (TOS) on Wed., March 19, 12pm ET for a briefing on the risks of compounded obesity drugs. This event is open to patient and provider advocacy groups, Capitol Hill staffers, regulatory professionals, media, and the public. Register here: bit.ly/41BNN9J
19.03.2025 10:34 — 👍 0 🔁 0 💬 0 📌 0
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
My latest post: The MAHA Challenge: Can It Lead to a Healthier and Safer Food Supply? The latest from FDA Matters, The Grossman FDA Report. Read here: www.fdamatters.com
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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #trump #maha #rfkjr #foodpolicy #healthyeating
18.03.2025 15:34 — 👍 1 🔁 0 💬 0 📌 0
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
Zero-Based Defense (ZBD) of Critical Government Programs, Passage of FY 25 CR: FDA Level-Funded But Other Programs Hit, Multiple Budget Battles Yet to Come: FDA at Continued Risk, What I am Reading: Proposed Cuts to Medicaid. Read more: www.fdamatters.com
#FDA #FDAMatters
14.03.2025 17:21 — 👍 0 🔁 0 💬 0 📌 0
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
The latest from FDA Matters, The Grossman FDA Report: What I Learned By Speaking About “FDA in Trump 2.0”. Read here: www.fdamatters.com
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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #trump #AmericasBloodCenters
12.03.2025 14:26 — 👍 0 🔁 0 💬 0 📌 0
