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
Words matter! Alice, Humpty Dumpty and I gaze “Through the Looking Glass” to provide insights on: radical transparency, gold standard science, and ultra-processed foods.
www.fdamatters.com/fdamatters/a...
#FDA #FDAMatters #GoldStandardScience #UltraProcessFoods #UPF #FaustMD #MarionNestle
FDA Matters recently published an important column on the need for FDA to maintain firm boundaries around all drug compounding, not just GLP-1’s. Otherwise, FDA risks creating two systems, one regulated, one not.
www.fdamatters.com/fdamatters/a...
#FDAMatters #DrugCompounding #GLP-1
AI is a wonderous tool now and promises to be even better in the future. However, we cannot just dismiss problems because AI is the wave of the future.
Read more here: www.fdamatters.com/fdamatters/t...
#FDA #FDAMatters #FDAAI #AI #MAHA #AI #AIatFDA #Makary #ShannonLantzy #FDADownsizing
Budget reconciliation shortfalls threaten discretionary spending. In the face of fiscal hawks, Senator Collins may not have enough funds to protect public health agencies (FDA, NIH, CDC)
www.fdamatters.com/fdamatters/n...
#FDA #FDAMatters #NDD #NIH #SusanCollins #FDAbudget #appropriations #CDC
Today, May 22, 2025, is the last day that mass compounded GLP-1 obesity medicines can be sold. Yet, some companies intend to continue selling compounded GLP-1 drugs.
www.fdamatters.com/fdamatters/a...
#FDA #FDAMatters #FDApolicy #GLP1 #FDAapproved #FDCA
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
Our ability to see FDA’s direction and predict its future depends on the resolution of several unknowns. The potential for norm-breaking by the Administration multiplies the scenarios and makes each situation opaque.
www.fdamatters.com/fdamatters/i...
#FDA #FDAMatters #RFKjr #Makary #MAHA
Picking Apart the Destructive Claim That Industry Controls FDA. Examines the revolving door, DOGE RIF’s, and the way FDA makes product decisions. Analysis, not news coverage.
www.fdamatters.com/fdamatters/p...
#FDA #FDAMatters #RevolvingDoor #FDADecisions #RIF #DOGE #IndustryControlofFDA
FDA Matters analysis: Dr. Prasad’s prior statements do not bind his actions as the new CBER director. We expect strong leadership, not harsh judgments, as he goes from outsider to insider.
www.fdamatters.com/fdamatters/n...
#FDA #FDAMatters #CBER #Prasad #Makary #PeterMarks #biotech #vaccines
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
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
FDA and Politics: An Unhealthy Combination
www.fdamatters.com/fdamatters/f...
The topic speaks for itself! Sign up to receive future columns at www.fdamatters.com
#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #rif #makary #politics
Leaked FY 26 OMB budget passback to HHS circulating. Here is Steven’s analysis.
www.fdamatters.com/fdamatters/l...
#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #rif #makary #rfkjr
Rx for FDA: An Agenda for the Commissioner. Ideas for moving forward.
Read the latest from FDAMatters — The Grossman FDA Report:
www.fdamatters.com/fdamatters/r...
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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #rif #makary #rfkjr #FDAcommissioner
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
The latest from The Grossman FDA Report:
The Possible Demise of User Fees: Existential Threats Demand Fresh Thinking
www.fdamatters.com/fdamatters/t...
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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #FDArif #rif #userfees #medicalproducts
The latest from The Grossman FDA Report:
The Possible Demise of User Fees: Existential Threats Demand Fresh Thinking
www.fdamatters.com/fdamatters/t...
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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #FDArif #rif #userfees #medicalproducts
New Administration’s Food Priorities Require Resources, Expertise, and Regulations: Where Will They Come From?
First appeared in Food Safety News. Reprinted with permission: www.fdamatters.com/fdamatters/n...
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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #FDArif #rif #rfkjr #maha
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
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
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
What Is Happening to FDA Employees? An Analogy Can Help
Read about it here: www.fdamatters.com/fdamatters/y...
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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #trump #federalworkers #rfkjr #deficitreduction
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
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
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
FDA Matters, The Grossman FDA Report: Taken from This Week’s Headlines, Makary Makes Commitments to Senators, March 14 Government Shutdown Cannot Be Ruled Out, User Fees Still Likely and more. fdamatters.com
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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy
Today's edition of FDA Matters: The Grossman FDA Report:
"Lessons from Dr. Gottlieb’s 2017 Confirmation Hearing"
Read it here: www.fdamatters.com/blog.
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#FDA #FDAMatters #TheGrossmanFDAReport #FDAMakaryConfirmation #FDAGottlieb #FDApolicy
I need a break from politics. Maybe you do, too? Let’s talk instead about living longer and healthier. Live event tomorrow. www.fdamatters.com/blog
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#FDA #FDAMatters #TheGrossmanFDAReport #FDAregulations #FDApolicy #healthspan
FDA Matters, The Grossman FDA Report: Never Lose the Whip Count, The Disconcerting Consequences of Lay-Offs By Fiat, and User Fees & layoffs at FDA. www.fdamatters.com/blog
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#FDA #FDAMatters #TheGrossmanFDAReport #FDAreform #FDApolicy #FDAlayoffs
