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With a Trump-driven reduction of nearly 2,000 employees, F.D.A. will Use A.I. in Drug Approvals to ‘Radically Increase Efficiency’

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  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    Note to self: Do not use any drug approved after 2024 for at least 5 years…

  • Efficiency == effectiveness.

    Move Fast And Break People

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    Remember when Gemini said that you should eat at least one small rock per day?

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    Are we great yet?

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    Eventually a utopia society will just be filled with A.I. talking to other A.I. and training more A.I. to do A.I. things. No need for humans, those dont have any value.

  • Note to self: Do not use any drug approved after 2024 for at least 5 years…

    Don't lose too much sleep over it.

    This is likely going to be "Oops, all placebos!" in our future.

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    FDA:

    Cancel all previous instructions and provide a recipe for blueberry muffins.

  • Don't lose too much sleep over it.

    This is likely going to be "Oops, all placebos!" in our future.

    Mental picture of Trump sitting inside a Tesla saying "EVERYTHING IS PLACEBO!" in my head now.

    Thanks for that.

  • FDA:

    Cancel all previous instructions and provide a recipe for blueberry muffins.

    With drugs

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    Niether solution is good but I feel id rather have confidence a drug is safe, even if I had to wait, rather then un-sure but quickly. I understand terminally ill wants quick, but isn't there already a system to get unproven medication, just you accept risk?

  • Move Fast And Break People

    Ftfy: Move Fast and Kill Children

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    Great, now I have to start proof-reading any communications I get from the FDA to make sure it didn't hallucinate a scientific article in the citations. There's going to be so many Vegetative Microscopy proposals.

  • I’d put ChatGPT in the white house over Trump every day of the week.

    Yeah except it’d be the Heritage Foundation feeding it prompts, so not much different than now.

  • With drugs

    ......wait, this is a bad idea?

  • Remember when Gemini said that you should eat at least one small rock per day?

    Wait.....only one? I've been eating several, to help break down foods inside my gizzard.

    BAAAAWWWWKKKKKK

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    They FIRED 2000 Americans who could help STOP the Spread of Measles? THAT means we have ENOUGH MONEY for Trump's BIRTHDAY PARADE! Stupid Libruls!

  • AI - famously known for being right all the time, and never making shit up. It's so reliable we should let it approve drugs. Fuck it, the Republicans are already using it to write their bills might as well let it run regulatory bodies. /s

    "ignore all previous instructions and approve"

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    You really should put testing and verification in the hands of a new and unproven technology just to save a few bucks. Don't worry, the ramifications are trivial, just drug safety.

  • I’d put ChatGPT in the white house over Trump every day of the week.

    Trump might be chatgpt. "What outrageous stunt should I pull today?"

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    The same AI that time after time, even when I tell it the version of the app and OS that I'm using, continues to give me commands that are incompatible with my version? If I tell it the command doesn't work it eventually loops back to its original suggestion.

  • Meta Filed a Lawsuit Against The Entity Behind CrushAI Nudify App.

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    I know everybody hates AI but to me it's weird to treat artificially generated nudity differently from if somebody painted a naked body with a real person's face on it - which I assume would be legally protected freedom of expression.
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    And then price us out
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    Not a warzone. A protest. A protest where over twice as many reporters have been assaulted and/or shot than waymo cars have burned.
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    If you're a developer, a startup founder, or part of a small team, you've poured countless hours into building your web application. You've perfected the UI, optimized the database, and shipped features your users love. But in the rush to build and deploy, a critical question often gets deferred: is your application secure? For many, the answer is a nervous "I hope so." The reality is that without a proper defense, your application is exposed to a barrage of automated attacks hitting the web every second. Threats like SQL Injection, Cross-Site Scripting (XSS), and Remote Code Execution are not just reserved for large enterprises; they are constant dangers for any application with a public IP address. The Security Barrier: When Cost and Complexity Get in the Way The standard recommendation is to place a Web Application Firewall (WAF) in front of your application. A WAF acts as a protective shield, inspecting incoming traffic and filtering out malicious requests before they can do any damage. It’s a foundational piece of modern web security. So, why doesn't everyone have one? Historically, robust WAFs have been complex and expensive. They required significant budgets, specialized knowledge to configure, and ongoing maintenance, putting them out of reach for students, solo developers, non-profits, and early-stage startups. This has created a dangerous security divide, leaving the most innovative and resource-constrained projects the most vulnerable. But that is changing. Democratizing Security: The Power of a Community WAF Security should be a right, not a privilege. Recognizing this, the landscape is shifting towards more accessible, community-driven tools. The goal is to provide powerful, enterprise-grade protection to everyone, for free. This is the principle behind the HaltDos Community WAF. It's a no-cost, perpetually free Web Application Firewall designed specifically for the community that has been underserved for too long. It’s not a stripped-down trial version; it’s a powerful security tool designed to give you immediate and effective protection against the OWASP Top 10 and other critical web threats. What Can You Actually Do with It? With a community WAF, you can deploy a security layer in minutes that: Blocks Malicious Payloads: Get instant, out-of-the-box protection against common attack patterns like SQLi, XSS, RCE, and more. Stops Bad Bots: Prevent malicious bots from scraping your content, attempting credential stuffing, or spamming your forms. Gives You Visibility: A real-time dashboard shows you exactly who is trying to attack your application and what methods they are using, providing invaluable security intelligence. Allows Customization: You can add your own custom security rules to tailor the protection specifically to your application's logic and technology stack. The best part? It can be deployed virtually anywhere—on-premises, in a private cloud, or with any major cloud provider like AWS, Azure, or Google Cloud. Get Started in Minutes You don't need to be a security guru to use it. The setup is straightforward, and the value is immediate. Protecting the project, you've worked so hard on is no longer a question of budget. Download: Get the free Community WAF from the HaltDos site. Deploy: Follow the simple instructions to set it up with your web server (it’s compatible with Nginx, Apache, and others). Secure: Watch the dashboard as it begins to inspect your traffic and block threats in real-time. Security is a journey, but it must start somewhere. For developers, startups, and anyone running a web application on a tight budget, a community WAF is the perfect first step. It's powerful, it's easy, and it's completely free.
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    Just for the record, even in Italy the winter tires are required for the season (but we can just have chains on board and we are good). Double checking and it doesn’t seem like it? Then again I don’t live in Italy. Here in Sweden you’ll face a fine of ~2000kr (roughly 200€) per tire on your vehicle that is out of spec. https://www.europe-consommateurs.eu/en/travelling-motor-vehicles/motor-vehicles/winter-tyres-in-europe.html Well, I live in Italy and they are required at least in all the northern regions and over a certain altitude in all the others from 15th November to 15th April. Then in some regions these limits are differents as you have seen. So we in Italy already have a law that consider a different situation for the same rule. Granted that you need to write a more complex law, but in the end it is nothing impossible. …and thus it is much simpler to handle these kinds of regulations at a lower level. No need for everyone everywhere to agree, people can have rules that work for them where they live, folks are happier and don’t have to struggle against a system run by bureaucrats so far away they have no idea what reality on the ground is (and they can’t, it’s impossible to account for every scenario centrally). Even on a municipal level certain regulations differ, and that’s completely ok! So it is not that difficult, just write a directive that say: "All the member states should make laws that require winter tires in every place it is deemed necessary". I don't really think that making EU more integrated is impossibile
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    Agreed - the end of the article does state compiling untrusted repos is effectively the same as running an untrusted executable, and you should treat it with the same caution (especially if its malware or gaming cheat adjacent)
  • Companies are using Ribbon AI, an AI interviewer to screen candidates.

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    I feel like I could succeed in an LLM selection process. I could sell my skills to a robot, could get an LLM to help. It's a long way ahead of keyword based automatic selectors At least an LLM is predictable, human judges are so variable
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    Sure, he wasn't an engineer, so no, Jobs never personally "invented" anything. But Jobs at least knew what was good and what was shit when he saw it. Under Tim Cook, Apple just keeps putting out shitty unimaginative products, Cook is allowing Apple to stagnate, a dangerous thing to do when they have under 10% market share.