I would love to hear what an adcomm would say -- should the black box be replaced with other specific warnings?
October 30, 2026 at 4:52 PM
I would love to hear what an adcomm would say -- should the black box be replaced with other specific warnings?
$BHVN's Vyglxia NDA resubmission for spinocerebellar ataxia accepted by FDA; PDUFA set for Q1 2027, with AdComm review expected. $GUTS $SXTC $NBTX $ABUS $AAPG $NCEL $AKAN $NIVF $RCUS
www.biopharmcatalyst.com/news/2026/bi...
www.biopharmcatalyst.com/news/2026/bi...
Pre-Market Updates 10/22/26
export-download.canva.com
October 22, 2026 at 12:40 PM
$BHVN's Vyglxia NDA resubmission for spinocerebellar ataxia accepted by FDA; PDUFA set for Q1 2027, with AdComm review expected. $GUTS $SXTC $NBTX $ABUS $AAPG $NCEL $AKAN $NIVF $RCUS
www.biopharmcatalyst.com/news/2026/bi...
www.biopharmcatalyst.com/news/2026/bi...
“Not conducting the trial would result in definite harm”
Reminds me of the fed. adcomm. mtg. where an "expert" argued that kids randomized to a placebo arm in an oncology trial would benefit by not being exposed to possible chemo SAEs. Underwear-on-head batshit stuff.
Reminds me of the fed. adcomm. mtg. where an "expert" argued that kids randomized to a placebo arm in an oncology trial would benefit by not being exposed to possible chemo SAEs. Underwear-on-head batshit stuff.
October 14, 2026 at 5:06 PM
“Not conducting the trial would result in definite harm”
Reminds me of the fed. adcomm. mtg. where an "expert" argued that kids randomized to a placebo arm in an oncology trial would benefit by not being exposed to possible chemo SAEs. Underwear-on-head batshit stuff.
Reminds me of the fed. adcomm. mtg. where an "expert" argued that kids randomized to a placebo arm in an oncology trial would benefit by not being exposed to possible chemo SAEs. Underwear-on-head batshit stuff.
STAT #News (Health & Medicine): #FDA adcomm members’ ties to industry under scrutiny - https://kensbookinfo.blogspot.com/p/end-of-line.html#STATNewsHealth&Medicine
October 14, 2026 at 10:11 PM
STAT #News (Health & Medicine): #FDA adcomm members’ ties to industry under scrutiny - https://kensbookinfo.blogspot.com/p/end-of-line.html#STATNewsHealth&Medicine
STAT #News (Health & Medicine): #FDA adcomm members’ ties to industry under scrutiny - https://kensbookinfo.blogspot.com/p/end-of-line.html#STATNewsHealth&Medicine
October 14, 2026 at 8:34 PM
STAT #News (Health & Medicine): #FDA adcomm members’ ties to industry under scrutiny - https://kensbookinfo.blogspot.com/p/end-of-line.html#STATNewsHealth&Medicine
STAT+: FDA adcomm members' ties to industry under scrutiny
STAT News
https://www.statnews.com/2026/10/14/biotech-news-fda-adcomm-member-ties-to-industry-under-scrutiny/?utm_campaign=rss
STAT News
https://www.statnews.com/2026/10/14/biotech-news-fda-adcomm-member-ties-to-industry-under-scrutiny/?utm_campaign=rss
STAT+: FDA adcomm members' ties to industry under scrutiny
STAT News
www.statnews.com
October 14, 2026 at 2:20 PM
STAT+: FDA adcomm members' ties to industry under scrutiny
STAT News
https://www.statnews.com/2026/10/14/biotech-news-fda-adcomm-member-ties-to-industry-under-scrutiny/?utm_campaign=rss
STAT News
https://www.statnews.com/2026/10/14/biotech-news-fda-adcomm-member-ties-to-industry-under-scrutiny/?utm_campaign=rss
The good news for #Grail is that the #FDA's panel of external experts voted in favour of its #Galleritest for multiple cancers at a meeting yesterday. The bad news is that the discussions revealed some had misgivings about the #bloodtest – even if they voted for it.
pharmaphorum.com/news/grail-c...
pharmaphorum.com/news/grail-c...
Grail cancer test gets lukewarm backing from FDA adcomm
FDA expert advisors voted in favour of Grail's Galleri blood test for detecting multiple cancers, but some expressed misgivings about its efficacy.
pharmaphorum.com
September 24, 2026 at 10:32 AM
The good news for #Grail is that the #FDA's panel of external experts voted in favour of its #Galleritest for multiple cancers at a meeting yesterday. The bad news is that the discussions revealed some had misgivings about the #bloodtest – even if they voted for it.
pharmaphorum.com/news/grail-c...
pharmaphorum.com/news/grail-c...
the copy-paste on radiloogy macros is a menace. An adcomm bringing that up would be the most entertaining fda meeting in years tbh
September 23, 2026 at 8:39 AM
the copy-paste on radiloogy macros is a menace. An adcomm bringing that up would be the most entertaining fda meeting in years tbh
This is why women are baffled from time to time when radiology reports indicate the testicles (they don't have) are unremarkable.
This might make for an unpleasant FDA adcomm mtg.
This might make for an unpleasant FDA adcomm mtg.
September 21, 2026 at 12:29 PM
This is why women are baffled from time to time when radiology reports indicate the testicles (they don't have) are unremarkable.
This might make for an unpleasant FDA adcomm mtg.
This might make for an unpleasant FDA adcomm mtg.
Oh ffs. Jaw implant/replacement devices?? Patient comments at FDA adcomm mtgs. were some of the most harrowing things I've ever read.
This barely scratches the regulatory history & the hideous suffering of patients. Early manufacturers & investigators caused, not relieved, suffering.
This barely scratches the regulatory history & the hideous suffering of patients. Early manufacturers & investigators caused, not relieved, suffering.
TMJ Device and Regulatory History - The TMJ Association
Learn about TMJ implants devices and its regulatory history.
tmj.org
September 19, 2026 at 2:23 AM
Oh ffs. Jaw implant/replacement devices?? Patient comments at FDA adcomm mtgs. were some of the most harrowing things I've ever read.
This barely scratches the regulatory history & the hideous suffering of patients. Early manufacturers & investigators caused, not relieved, suffering.
This barely scratches the regulatory history & the hideous suffering of patients. Early manufacturers & investigators caused, not relieved, suffering.
Since 1986, SlideSource has supported over 200 FDA Advisory Committee meetings and produced thousands of effective slides for the pharmaceutical industry. #FDA #AdComm
https://bit.ly/4bZH2SY
https://bit.ly/4bZH2SY
September 15, 2026 at 2:58 PM
Since 1986, SlideSource has supported over 200 FDA Advisory Committee meetings and produced thousands of effective slides for the pharmaceutical industry. #FDA #AdComm
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FDA advisory committee meeting presentations are critical. With 25+ years of experience, SlideSource ensures your program has the best chance for success. #RegulatorySuccess #FDA #AdComm
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September 11, 2026 at 9:49 PM
FDA advisory committee meeting presentations are critical. With 25+ years of experience, SlideSource ensures your program has the best chance for success. #RegulatorySuccess #FDA #AdComm
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After countless hours of research & development, you're going to an #FDA #AdComm. Our expertise, skills, and slide management tools can help you create the regulatory and clinical presentations that you will need to bring your science to life.
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>>>> https://bit.ly/3Go80D1
September 2, 2026 at 7:12 PM
After countless hours of research & development, you're going to an #FDA #AdComm. Our expertise, skills, and slide management tools can help you create the regulatory and clinical presentations that you will need to bring your science to life.
>>>> https://bit.ly/3Go80D1
>>>> https://bit.ly/3Go80D1
SlideSource offers expert guidance and support for #FDA #AdComm meetings, including core and backup slide development and rehearsal technology packages. Find out how we can help your team achieve AdComm success: https://bit.ly/3zBBsIh #FDAExperts
August 30, 2026 at 1:25 PM
SlideSource offers expert guidance and support for #FDA #AdComm meetings, including core and backup slide development and rehearsal technology packages. Find out how we can help your team achieve AdComm success: https://bit.ly/3zBBsIh #FDAExperts
Have an #FDA Advisory Committee Meeting presentation on the horizon?
We have vast experience helping clients avoid the many AdComm prep pitfalls. Get our whitepaper - The Seven Mistakes Teams Make When Preparing for an FDA Advisory Committee Presentation: https://bit.ly/3p9tw99
We have vast experience helping clients avoid the many AdComm prep pitfalls. Get our whitepaper - The Seven Mistakes Teams Make When Preparing for an FDA Advisory Committee Presentation: https://bit.ly/3p9tw99
August 18, 2026 at 4:42 PM
Have an #FDA Advisory Committee Meeting presentation on the horizon?
We have vast experience helping clients avoid the many AdComm prep pitfalls. Get our whitepaper - The Seven Mistakes Teams Make When Preparing for an FDA Advisory Committee Presentation: https://bit.ly/3p9tw99
We have vast experience helping clients avoid the many AdComm prep pitfalls. Get our whitepaper - The Seven Mistakes Teams Make When Preparing for an FDA Advisory Committee Presentation: https://bit.ly/3p9tw99
The Vaccines and Related Biological Products Advisory Committee meeting next month was scheduled to select strains for the 2025-2026 flu vaccine. The cancellation could mean delays in vaccine availability.
Breaking: US FDA Cancels Upcoming Adcomm Discussing 2025-2026 Flu Vaccine
The Vaccines and Related Biological Products Advisory Committee meeting next month was scheduled to select strains for the 2025-2026 flu vaccine. The cancellation could mean delays in vaccine availabi...
insights.citeline.com
February 27, 2025 at 12:12 AM
The Vaccines and Related Biological Products Advisory Committee meeting next month was scheduled to select strains for the 2025-2026 flu vaccine. The cancellation could mean delays in vaccine availability.
Join us for the chapter Work Day on Sat. 4/12 from 10:30am-2pm at Trinity Church. We’ll have formation meetings for AdComm, Electoral Working Group, and Green New Deal Working Group, plus time for working on projects. Breakfast and lunch will be provided. RSVP here: actionnetwork.org/events/chapt...
April 6, 2025 at 2:59 AM
Join us for the chapter Work Day on Sat. 4/12 from 10:30am-2pm at Trinity Church. We’ll have formation meetings for AdComm, Electoral Working Group, and Green New Deal Working Group, plus time for working on projects. Breakfast and lunch will be provided. RSVP here: actionnetwork.org/events/chapt...
FDA flags “major safety concerns” with andexanet 👀 www.fiercepharma.com/pharma/astra...
AstraZeneca to go on defense for Andexxa as FDA questions bleeding reversal agent's safety ahead of adcomm
As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.
www.fiercepharma.com
November 20, 2024 at 5:28 PM
FDA flags “major safety concerns” with andexanet 👀 www.fiercepharma.com/pharma/astra...
Worth noting that Tidmarsh & Makary expressed skepticism of adcomm meetings at a town hall in August, with Makary calling them bureaucratic and expensive and Tidmarsh questioning whether they were necessary at all. My story on those comments here: www.statnews.com/2025/08/08/f...
In internal FDA town hall, employees raise concerns about staffing, impromptu expert meetings
Exclusive: FDA employees, in a town hall after the ouster of Vinay Prasad, asked about unusual meetings and staff shortages. "We are struggling," one said.
www.statnews.com
September 12, 2025 at 7:19 PM
Worth noting that Tidmarsh & Makary expressed skepticism of adcomm meetings at a town hall in August, with Makary calling them bureaucratic and expensive and Tidmarsh questioning whether they were necessary at all. My story on those comments here: www.statnews.com/2025/08/08/f...
Breaking: US FDA Cancels Upcoming Adcomm Discussing 2025-2026 Flu Vaccine (Insights)
Main Link | memeorandum Permalink
Main Link | memeorandum Permalink
February 27, 2025 at 2:50 AM
Breaking: US FDA Cancels Upcoming Adcomm Discussing 2025-2026 Flu Vaccine (Insights)
Main Link | memeorandum Permalink
Main Link | memeorandum Permalink
Other adcomm panels for CDRH typically have one industry representative (and also one consumer representative)
November 21, 2024 at 7:59 PM
Other adcomm panels for CDRH typically have one industry representative (and also one consumer representative)
Is it a problem if patient advocacy groups influence FDA decisions? What about if those groups are partially funded by drug companies? A nice examination of these questions by my new colleague Heather McKenzie: www.biospace.com/article/upco...
Upcoming NurOwn Adcomm Highlights Regulatory Role for Patient Advocates
Recent drug approvals have shone a light on the role that patient advocacy groups can play in the regulatory process—but some experts have questions about the ethics of this influence.
www.biospace.com
September 25, 2023 at 3:42 PM
Is it a problem if patient advocacy groups influence FDA decisions? What about if those groups are partially funded by drug companies? A nice examination of these questions by my new colleague Heather McKenzie: www.biospace.com/article/upco...