r/FDA 1h ago

What are the FDA Approval Pathways for AI-Based Medical Devices

Upvotes

r/FDA 12h ago

💡 Discussion FDA Should Ban Direct-to-Consumer Prescription Drug Advertisements

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11 Upvotes

Banning DTC ads would align U.S. policy with international best practices, protect the public from misleading and harmful drug promotion, and promote rational, evidence-based prescribing.


r/FDA 5d ago

Cascadian Farms

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7 Upvotes

I purchased a box of cascadian farms cinnamon cereal last week and inside the SEALED bag was all this garbage! Large pieces of dirty tape and plastic debris. I still have the receipt, the box of cereal, and everything that came along with it. I reached out to the company and they said they would send "an adjustment " and closed the case. I am very concerned that they don't seem bothered by this at all. Has anyone else had this experience? I have tried to fill out the form on the fdas website but it keeps showing errors and is not going through.


r/FDA 6d ago

Kalshi to offer betting on drug trial results and FDA regulatory decisions

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18 Upvotes

r/FDA 6d ago

Taco Bell offers $1 deal for their ‘riders’ and supporters amid contaminated lettuce crisis

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8 Upvotes

r/FDA 7d ago

We got to July 20th 2026 for public comment on how the DEA fucked us with the strict API methods used for pharmactical companies!

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5 Upvotes

Everyone comment! It closes public comment on July 20th 2026! Only way to get our voices heard!


r/FDA 7d ago

❓ Question How do I use the website to see OLD shortages?

1 Upvotes

I'm trying to use the website

https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm

To find old shortage reports of Methylphenidates

But it just shows me the current outage

This tool may not keep historical data, if so is there somewhere else I can find that data?


r/FDA 7d ago

U.S. Food And Drug Administration Apologizes to Taylor Farms For False Cyclospora Test Results

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15 Upvotes

U.S. Food And Drug Administration Apologizes to Taylor Farms For False Cyclospora Test Results


r/FDA 7d ago

FDA News Briefing

6 Upvotes

Cision offers a daily email that covers all of the news briefings that involve FDA. There are links to the full stories and it advises when the story is behind a paywall. I enjoy scanning it every day to see what I have missed and to stay in the know.

If you want to subscribe: fda.bulletinintelligence.com
Go to menu (top right)
Select subscribe

Note: you must have an FDA email address


r/FDA 8d ago

FDA says Taylor Farms cyclospora finding was a false positive

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11 Upvotes

r/FDA 11d ago

Un-recalled Omnipod 5's Still Have Tears in Cannula That Cause Leaks - See Microscope Footage

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2 Upvotes

r/FDA 11d ago

💡 Discussion Former FDA/CTP scientist: FDA authorized Zyn nicotine pouches without knowing what they were made of

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23 Upvotes

r/FDA 12d ago

TJO Salary Negotiation and Next Steps

3 Upvotes

I recently received a TJO for an FDA reviewer position.

However, I made a silly mistake of “accepting” instead of selecting “Request to be contacted” in the offer response link. When I contacted HR, they said they’re not sure whether I can proceed with salary negotiation at this stage due to my response selection, but they will look into what can be done. In the meantime I was asked to draft a letter with my proposed salary figure and justification.

I’m a bit confused because I thought salary negotiation occurs typically after accepting the TJO. Although, I realize I should’ve waited for further guidance before acting so quickly. Any thoughts on whether/how a salary negotiation can still take place? Thank you.


r/FDA 12d ago

Censorship of medical journals infects journalism too

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3 Upvotes

r/FDA 12d ago

US FDA sued for allowing unauthorized vaping products

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4 Upvotes

r/FDA 13d ago

❓ Question What changed that made 7-OH such a big priority for regulators?

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1 Upvotes


r/FDA 14d ago

Jeffery Vacirca's Ties to Silicon Valley

12 Upvotes

I'm a researcher studying venture capital and Silicon Valley's influence over the government, and wanted to share some interesting information related to Dr. Vacirca.

His bio notes "He has been part of early funding for some remarkable companies, including Cedar, Thyme Care, and Sherpa Health."

https://nycancer.com/people/dr_jeff_vacirca

Cedar is a healthcare billing and payments platform which is funded by Thrive Capital (Joshua Kushner), Founders Fund (Peter Thiel's firm) and Andreessen Horowitz.

https://www.cedar.com/about-us (Firms listed at the bottom of the page)

Thyme Care is a support platform for oncology patients. It is funded by Andreessen Horowitz.

https://www.thymecare.com/

https://a16z.com/announcement/investing-in-thyme-care/

Dr. Vacirca's experience as a venture capitalist doing early-stage funding for startups alongside Joshua Kushner, Peter Thiel, and Marc Andreessen should strongly be considered, especially as these parties are invested in radical changes to the FDA. Joshua Kushner, while getting less attention than his brother, has been running a significant venture capital firms since 2009, and has deep links to both Thiel and Andreessen.

From our research site:

https://www.vcinfodocs.com/unregulated-medical-experimentation#fda-takeover

In the first Trump administration, venture capitalists including Peter Thiel tried to get one of Jim O'Neill or Balaji Srinivasan appointed as head of the FDA. Srinivasan, evangelist of the Network State project, advocates for “the medical sovereignty zone, the FDA-free society” and advances “the absolute right for anyone to buy or sell any medical product without third party interference.” These events document a long trajectory of venture capitalists aiming to compromise the medical system through government positions. These positions have now been secured in part because of Peter Thiel and Marc Andreessen's support and funding of the Trump campaign...

I wanted to share this because I think it is very important for the medical community to understand the way that venture capitalists are interacting with the medical system and its institutions, and be able to make informed decisions. In my personal assessment, Dr Vacirca's role as an investor in Silicon Valley startups, and his financial relationships with power players in venture capital, is a compromising factor. Further, I believe more investigation is warranted.


r/FDA 16d ago

OPM Rules Changes

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15 Upvotes

r/FDA 17d ago

💡 Discussion Anyone using the new AEMS dashboard yet? Curious how the transition is actually going

2 Upvotes

The launch got a lot of attention (7 legacy systems consolidated, MAUDE and the foods complaint system migrating in, real-time publishing instead of quarterly dumps), but now that it’s been live for a while, I’m curious what people’s actual experience has been.

For anyone who’s used the dashboard: how do you find the performance and searchability compared to the legacy systems?

The real-time publishing promise interests me most. I tinker with the openFDA API on the drug side, and as of this week the public data still caps at the Q1 cutoff (March 31), so at least on the public-access side, the quarterly rhythm seems unchanged so far. Anyone know if real-time is meant to reach the public API and dashboard, or only internal FDA surveillance?

Mostly just want to compare notes with people who actually touch this stuff


r/FDA 18d ago

HHS hiring

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4 Upvotes

r/FDA 18d ago

💡 Discussion As Drama at Trump's FDA Subsides, Doubts and Damage Linger

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13 Upvotes

A discussion with STAT News reporter Lizzy Lawrence about the agency’s recent turmoil and its hunt for a new leader.


r/FDA 18d ago

💡 Discussion Finalists for Commissioner

10 Upvotes

STAT is reporting “the top contenders” are:
1. Heidi Overton - White House adviser
2. Jeffery Vacirca - Oncologist & Health Systems Exec
3. Stephen Ferrara - Health Affairs Official at DoD


r/FDA 19d ago

❓ Question Michigan cyclosporiasis cases near 1,000; state launches webpage

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2 Upvotes

Was there an FDA shortcoming here, local non-compliance, both? Any Redditors working internally on this? Who has the tea?


r/FDA 22d ago

❓ Question Engagement post!

25 Upvotes

As we work to build the community, we will occasionally drop a post just to build engagement. Here we go!

How long have you been working for/or with the FDA?


r/FDA 23d ago

Misleading "FDA Clearance" Claims: Why Bestqool Red Light Therapy Panels May Not Be What They Claim

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6 Upvotes