explore | Grilled Cheese

What if AI’s best regulatory use isn’t writing your submission, but finding the weaknesses before FDA does?

In this clip from The Outsourcing Advisor, Bikash Chatterjee explains why AI may be most valuable as a stress test, not just a writing tool. shorturl.at/nbpSo
#AI #FDA #Biopharma #Outsourcing

The hand soap meant to clean your hands may be contaminated with bacteria #HandSoapRecall #FDA

Pharmalot.. Pharmalittle.. Good Morning: We’re reading about faster FDA approvals, access to experimental drugs in Montana, and more news.. www.statnews.com/pharmalot/20... #pharma #FDA #testosterone #340B #HIV #Novo #Gilead #JNJ #Montana

The #FDA has published the design of its expedited #InvestigationalNewDrug (IND) #pilot, part of a plan to restore #UScompetitiveness in #clinicalresearch, and will now accept applications to take part from study sponsors.

pharmaphorum.com/news/fda-unv...

After the 2024 FDA guidance, adoption of Predetermined Change Control Plans (PCCPs) increased among radiology AI devices, but better reporting transparency is needed. https://doi.org/10.1148/ryai.260385 #FDA #RadiologyAI #ML

OncoC4's Cesalatamig Gains FDA Fast Track Designation for Non-Small Cell Lung Cancer Treatment #USA #FDA #Rockville #OncoC4 #Cesalatamig

They control 85% of the government! Surely, no #American is dumb enough to be gaslit by this guy claiming he didn't kill our economy, enrich his family, Gas is almost $5/gallon, food poisoning is in many staples due to #fda cuts, and astronomical prices!
bsky.app/profile/cidb...

#Drug doubles life expectancy of pancreatic cancer patients 💊

The #FDA approved #daraxonrasib, from Revolution Medicines, after patients in a #Phase3 clinical trial lived twice as long as those on #chemotherapy. The drug was studied in #mice and #monkeys before #HumanTrials.

🔗 shorturl.at/BHYZd

Medical device sales representatives must promptly report adverse events per #FDA guidelines - especially incidents resulting in serious outcomes. Timely compliance is essential for manufacturers to meet regulatory obligations and manage #ProductsLiability risk.

medmarc.com/life-science...

次世代素材が集結する「高機能素材 Week」、脱フッ素の潮流を考える #FDA #千葉県 #PFAS #環境配慮 #幕張市

9月30日からの「高機能素材 Week」で、環境配慮型素材からの脱フッ素技術の最新トレンドを紹介します。各社の革新が私たちの生活を豊かにします。

The FDA held a public hearing on psychedelic medicines as doctors, veterans, pharmacists and therapists urged the agency to establish clearer standards for safety, access and treatment. Psychedelics have officially reached the federal-hearing stage. #FDA

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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