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audreydzhang.bsky.social
Not so many people here discussing #FDAPolicy #RxPolicy yet, but this one will be one to follow - for the first time, FDA exercises its FDORA power to expedite withdrawal of drugs initially approved via accelerated approval: www.bloomberg.com/news/article...

#HealthPolicy
FDA Tests New Power to Pull Some Fast-Tracked Drugs Off Market
Its first target is a cancer treatment from Oncopeptides given accelerated approval in 2021, which has since faced a study questioning its effectiveness.
www.bloomberg.com
October 6, 2023 at 12:38 AM
fdamatters.bsky.social
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
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
www.fdamatters.com
March 18, 2025 at 3:34 PM
fdamatters.bsky.social
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
Leaked FY 26 FDA Budget Document Explained — FDA Matters
There is a document widely-circulated this morning that purports to be the OMB passback to HHS of the draft proposed FY 26 HHS President’s budget request. It includes proposed numbers for FDA funding ...
www.fdamatters.com
April 17, 2025 at 5:05 PM
fdamatters.bsky.social
"We are going to eliminate FEMA," @Sec_Noem (on X) says in Cabinet meeting with Trump. (h/t @JenniferJJacobs on X)
Steven's thoughts: www.fdamatters.com/fdamatters/p...
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#FDA #FDAMatters#TheGrossmanFDAReport #FDApolicy #trump #FEMA
Planning is a Virtue, But Government Agencies Are Paid to Deliver Results — FDA Matters
The Federal Emergency Management Agency (FEMA) is responsible for helping the American people before, during, and after a disaster. It has vast responsibilities and the unenviable burden of never know...
www.fdamatters.com
March 24, 2025 at 7:12 PM
fdamatters.bsky.social
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
A Dangerous Idea: Two Drug Manufacturing Pathways–One Regulated, One Not — FDA Matters
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 to a large number of their customer...
www.fdamatters.com
May 22, 2025 at 1:05 PM
fdamatters.bsky.social
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
FDA and Politics: An Unhealthy Combination — FDA Matters
Dr. Makary is a physician, healthcare quality and outcomes researcher, and self-styled iconoclast. When he accepted the Commissioner position in November 2024, I am sure he believed that Trump 2.0 wou...
www.fdamatters.com
April 22, 2025 at 5:32 PM
fdamatters.bsky.social
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
Rx for FDA: An Agenda for the Commissioner — FDA Matters
While FDA’s responsibilities have not changed, its capacity to perform its duties has been significantly reduced. After subtracting approximately 4,500 employees  from the agency’s 19,000 employe...
www.fdamatters.com
April 15, 2025 at 5:09 PM
fdamatters.bsky.social
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
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
www.fdamatters.com
April 11, 2025 at 5:55 PM
fdamatters.bsky.social
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 Possible Demise of User Fees: Existential Threats Require Outside-the-Box Thinking — FDA Matters
Last Thursday, Alec Gaffney of AgencyIQ declared “…the future of FDA’s user fee programs is in extreme jeopardy” ( here ). Alec has a well-deserved reputation as one of the best FDA analysts. Alec t...
www.fdamatters.com
April 7, 2025 at 9:31 PM
fdamatters.bsky.social
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 Possible Demise of User Fees: Existential Threats Require Outside-the-Box Thinking — FDA Matters
Last Thursday, Alec Gaffney of AgencyIQ declared “…the future of FDA’s user fee programs is in extreme jeopardy” ( here ). Alec has a well-deserved reputation as one of the best FDA analysts. Alec t...
www.fdamatters.com
April 7, 2025 at 9:31 PM
fdamatters.bsky.social
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
New Administration’s Food Priorities Require Resources, Expertise, and Regulations:Where Will They Come From? — FDA Matters
First appeared in Food Safety News . Reprinted with permission. ------------------------------ Se cretary Kennedy’ announcement ca me last Thursday : FDA’s contribution to the pending HHS reduct...
www.fdamatters.com
April 4, 2025 at 12:55 PM
fdamatters.bsky.social
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
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
www.fdamatters.com
March 25, 2025 at 9:24 PM
fdamatters.bsky.social
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
Your Brother-In-law Keeps Asking: What Is Happening to Federal Workers at FDA? — FDA Matters
The Federal Workforce is Large….FDA’s Is Small But Important Deficit Reduction Will Reduce the Federal Workforce….FDA Is Affected But Not Specifically Targeted President Clinton Significantl...
www.fdamatters.com
March 21, 2025 at 8:09 PM
fdamatters.bsky.social
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
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
www.fdamatters.com
March 12, 2025 at 2:26 PM
fdamatters.bsky.social
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
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
fdamatters.com
March 7, 2025 at 4:16 PM
fdamatters.bsky.social
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
Subscribe to The Grossman FDA Report — FDA Matters
Get the latest updates on the FDA from The Grossman FDA Report, brought to you by Steven Grossman.
www.fdamatters.com
March 4, 2025 at 7:10 PM
fdamatters.bsky.social
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
Subscribe to The Grossman FDA Report — FDA Matters
Get the latest updates on the FDA from The Grossman FDA Report, brought to you by Steven Grossman.
www.fdamatters.com
February 27, 2025 at 7:58 PM
fdamatters.bsky.social
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
Subscribe to The Grossman FDA Report — FDA Matters
Get the latest updates on the FDA from The Grossman FDA Report, brought to you by Steven Grossman.
www.fdamatters.com
February 25, 2025 at 10:57 PM
fdamatters.bsky.social
FDA, RIF's, and User Fees Explained in today's SPECIAL EDITION of FDA Matters: The Grossman FDA Report: www.fdamatters.com!
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#FDA #FDAMatters #TheGrossmanFDAReport #FDAreform #FDApolicy #FDAregulations #FutureofFDA #FDARIF #RIF #UserFees
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
www.fdamatters.com
February 23, 2025 at 10:13 PM
fdamatters.bsky.social
NEW: “FDA Matters: Short Takes & Updates—Feb. 20, 2025” at www.fdamatters.com: four threats to FDA’s mission.

About FDA lay-offs “If Being Mission-Critical Isn’t Important Enough, What Is?”

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#FDA #FDAMatters #TheGrossmanFDAReport #FDAbudget #FDApolicy #RIF
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
www.fdamatters.com
February 20, 2025 at 5:36 PM
fdamatters.bsky.social
See today's edition of FDA Matters: “If Being Mission-Critical Is Not Important Enough, What Is?” at fdamatters.com/blog! Today’s column looks at the lay-offs of FDA probationary employees over the holiday weekend.

#FDA #FDAMatters #TheGrossmanFDAReport #FDAreform #FDApolicy #FDAregulations #FDARIF
Subscribe to The Grossman FDA Report — FDA Matters
Get the latest updates on the FDA from The Grossman FDA Report, brought to you by Steven Grossman.
fdamatters.com
February 18, 2025 at 8:11 PM
fdamatters.bsky.social
See today’s FDA Matters’ “Short Takes and Updates” at www.fdamatters.com! It looks at the future of FDA user fees…and updates my column on FDA and budget reconciliation.

#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #FDAregulations #FDAuserFees #BudgetReconciliation
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
www.fdamatters.com
February 14, 2025 at 4:39 PM
electricbluesfan.bsky.social
2/13 The demands represent "an extraordinary flex" of Kennedy's power to make decisions typically left to career scientists at the FDA, injecting his long-held vaccine skepticism into federal policy decisions.
#Vaccines #HealthPolicy #FDAPolicy
May 2, 2025 at 3:00 PM
sarahkarlin-smith.bsky.social
Commissioner says agency’s speech restrictions to protect confidential commercial information ‘have gone too far,’ and may need to be modified to tackle spread of misinformation.
#healthpolicy #fdapolicy
pink.citeline.com/PS148974/Pha...
October 9, 2023 at 2:04 PM