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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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  • Oh my God. The reasons why I am happy not to be an American are stacking thicker every week.

    Only weekly?

  • ......wait, this is a bad idea?

    Depends, did you take the drugs 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.”

    Can AI reliably tell if a cat is longer than a banana yet?

  • Depends, did you take the drugs yet?

    No. I was hoping they'd be blueberry flavored!

  • This could be a good use of AI. Since this regime is doing it, and since some of their claims are pretty unrealistic, it probably won't be. But, ML has been used for a while to help identify new drug compounds, find interactions, etc. It could be very useful in the FDA's work - I'm honestly surprised to hear that they're only just now considering using it.

    The Four Thieves Vinegar Collective uses some software from MIT ASKCOS that uses neural networks to help identify reactions and retrosynthesis chains to produce chemical compounds using cheap, homemade bioreactors. Famously, they are doing this to make mifepristone available for people in areas of the US without access to abortion care.

    You can check it out here. It's a good example of a very positive use-case for an AI/ML tool in medicine.

    Properly implemented machine learning, sure.

    These dimwits are genuinely just gonna feed everything to a second rate LLM and treat the output as the word of God.

  • 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.”

    Efficiency =/= Accuracy or safety

    I can efficiently put a screw in drywall with an electric drill, but it doesn’t mean it will hold it up or attach it to anything.

  • 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 guy on the photo has the bottom half of a huge head and the eyes up of a small head. Totally weird.

  • No. I was hoping they'd be blueberry flavored!

    That's on the way out

  • Can AI reliably tell if a cat is longer than a banana yet?

    An african cat or a european cat?

  • 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.”

    ai has a place in drug development, but this is not how it should be used at all

    there should always be a reliable human system to double check the results of the model

  • 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.”

    So we're going to depend on AI, which can't reliably remember how many fingers humans have, to take over medical science roles. Neat!

  • 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.”

    This country is fucking toast moment #236

  • Discouraging use of artificial dye is a good idea. It interferes with people's ability to make health conscious choices. Requiring labeling would be a great start.

    Food dye is used to cover up a lot of food crime. Most of us wouldn't eat food that needs to be dyed to look safe to eat, if it weren't dyed, if we had a choice.

    Using AI to fast track food regulations is a terrible idea.

    Edit: Good point that "artificial" is part of their witch hunt wording. I only mean we could probably do with less dye use, or clear labels on what has been dyed.

    its coming from worm brains who consumes methlyene blue, which is a dye in itself.

  • 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.”

    i think people will go over to canada, or even mexico for real drugs, no ones going to risk a "supplement" like industry.

  • Don't lose too much sleep over it.

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

    Taking a drug that doesn't work is not necessarily the same as taking a placebo. I have suffered a lot from drug side effects, and some have hurt me long-term, years after I stopped taking the medicine. I am incredibly wary of taking anything new, even before all the horrors of 2025. With even worse approval processes, I expect that a lot of harmful and potentially debilitating or deadly stuff is going to end up on pharmacy shelves soon.

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

    Monkey paw finger curls inward

  • So we're going to depend on AI, which can't reliably remember how many fingers humans have, to take over medical science roles. Neat!

    Different types of AI, different training data, different expectations and outcomes. Generative AI is but one use case.

    It's already been proven a useful tool in research, when directed and used correctly by an expert. It's a tool, to give to scientists to assist them, not replace them.

    If you're goal to use AI to replace people, you've got a bad surprise coming.

    If you're not equipping your people with the skills and tools of AI, your people will become obsolete in short time.

    Learn AI and how to utilize it as a tool, you can train your own model on your own private data and locally interrogate the model to do unique analysis typically not possible in realtime. Learn the goods and bads of technology and let your ethics guide how you use it, but stop dismissing revolutionary technology because the earlier generative models weren't reinforced enough get fingers right.

  • 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.”

    Things LLM can't do well without extensive checking on large corpus of data:

    • summarizing
    • providing informed opinions

    What is it they want to make "more efficient" again? Digesting thousands of documents, filter extremely specific subset of data, and shorten the output?

    Oh.

  • Different types of AI, different training data, different expectations and outcomes. Generative AI is but one use case.

    It's already been proven a useful tool in research, when directed and used correctly by an expert. It's a tool, to give to scientists to assist them, not replace them.

    If you're goal to use AI to replace people, you've got a bad surprise coming.

    If you're not equipping your people with the skills and tools of AI, your people will become obsolete in short time.

    Learn AI and how to utilize it as a tool, you can train your own model on your own private data and locally interrogate the model to do unique analysis typically not possible in realtime. Learn the goods and bads of technology and let your ethics guide how you use it, but stop dismissing revolutionary technology because the earlier generative models weren't reinforced enough get fingers right.

    when directed and used correctly by an expert

    They're also likely to fire the experts.

  • 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.”

    IF bribe_received: return ("Approved")

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    It's clear you don't really understand the wider context and how historically hard these tasks have been. I've been doing this for a decade and the fact that these foundational models can be pretrained on unrelated things then jump that generalization gap so easily (within reason) is amazing. You just see the end result of corporate uses in the news, but this technology is used in every aspect of science and life in general (source: I do this for many important applications).
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    California is not Colorado nor is it federal No shit, did you even read my comment? Regulations already exist in every state that ride share companies operate in, including any state where taxis operate. People are already not supposed to sexually assault their passengers. Will adding another regulation saying they shouldn’t do that, even when one already exists, suddenly stop it from happening? No. Have you even looked at the regulations in Colorado for ride share drivers and companies? I’m guessing not. Here are the ones that were made in 2014: https://law.justia.com/codes/colorado/2021/title-40/article-10-1/part-6/section-40-10-1-605/#%3A~%3Atext=§+40-10.1-605.+Operational+Requirements+A+driver+shall+not%2Ca+ride%2C+otherwise+known+as+a+“street+hail”. Here’s just one little but relevant section: Before a person is permitted to act as a driver through use of a transportation network company's digital network, the person shall: Obtain a criminal history record check pursuant to the procedures set forth in section 40-10.1-110 as supplemented by the commission's rules promulgated under section 40-10.1-110 or through a privately administered national criminal history record check, including the national sex offender database; and If a privately administered national criminal history record check is used, provide a copy of the criminal history record check to the transportation network company. A driver shall obtain a criminal history record check in accordance with subparagraph (I) of paragraph (a) of this subsection (3) every five years while serving as a driver. A person who has been convicted of or pled guilty or nolo contendere to driving under the influence of drugs or alcohol in the previous seven years before applying to become a driver shall not serve as a driver. If the criminal history record check reveals that the person has ever been convicted of or pled guilty or nolo contendere to any of the following felony offenses, the person shall not serve as a driver: (c) (I) A person who has been convicted of or pled guilty or nolo contendere to driving under the influence of drugs or alcohol in the previous seven years before applying to become a driver shall not serve as a driver. If the criminal history record check reveals that the person has ever been convicted of or pled guilty or nolo contendere to any of the following felony offenses, the person shall not serve as a driver: An offense involving fraud, as described in article 5 of title 18, C.R.S.; An offense involving unlawful sexual behavior, as defined in section 16-22-102 (9), C.R.S.; An offense against property, as described in article 4 of title 18, C.R.S.; or A crime of violence, as described in section 18-1.3-406, C.R.S. A person who has been convicted of a comparable offense to the offenses listed in subparagraph (I) of this paragraph (c) in another state or in the United States shall not serve as a driver. A transportation network company or a third party shall retain true and accurate results of the criminal history record check for each driver that provides services for the transportation network company for at least five years after the criminal history record check was conducted. A person who has, within the immediately preceding five years, been convicted of or pled guilty or nolo contendere to a felony shall not serve as a driver. Before permitting an individual to act as a driver on its digital network, a transportation network company shall obtain and review a driving history research report for the individual. An individual with the following moving violations shall not serve as a driver: More than three moving violations in the three-year period preceding the individual's application to serve as a driver; or A major moving violation in the three-year period preceding the individual's application to serve as a driver, whether committed in this state, another state, or the United States, including vehicular eluding, as described in section 18-9-116.5, C.R.S., reckless driving, as described in section 42-4-1401, C.R.S., and driving under restraint, as described in section 42-2-138, C.R.S. A transportation network company or a third party shall retain true and accurate results of the driving history research report for each driver that provides services for the transportation network company for at least three years. So all sorts of criminal history, driving record, etc checks have been required since 2014. Colorado were actually the first state in the USA to implement rules like this for ride share companies lol.
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