FDA

“Rendesivir should be broadly and widely available right now. People shouldn't have to file for compassionate use to get it. They should be making it, printing it should be in every hospital, and people can decide whether or not they want to take the risk.”

“But if by health system, we mean the FDA, the CDC the WHO, which is part of the U S system, but we do rely on them to some extent. You've just seen, I think, you know, amazing really malpractice or negligence. If they were a pharma company, I think they'd be s…”

“And so, you know, I think the FDA did the right thing giving emergency trial authorization to doctors to be able to try this with their patients.”

“Every single Alzheimer's drug that's ever gone through the FDA has been rejected and has failed.”

“These people have nothing to lose, and so I would let the drug through, I think, and then watch how it performs over the next couple of years. They could always revoke the approval in two years, you know. In other words, almost consider the usage of the drug o…”

“There are currently 27 FDA-approved cell and gene therapies on the market. There are over a thousand in clinical trials, many of which are already showing extraordinary efficacy and benefit.”

“There are closed loop systems. We have one right now that's in front of the FDA. That is a total closed loop system that will not need any human input.”

“And what we will do by racing to create a new FDA is destroying American innovation in the sector, and other countries will not slow down. They will beat us to the punch here.”

“I think people would be far more. Scrutinizing of the medicines they took if it didn't come with the crowding out effect of that individual level of self-responsibility and due diligence that the government wasn't doing.”

“Now, he works for the FDA, and he runs the group that oversees which antigen test gets approved. I know this because he would write scathing letters to the ones he rejected that you can also look up online. Now, guess what? You're not going to be surprised. Fi…”

“The FDA only lets you queue up clinical trials to test drugs that are for diseases, but aging is not a disease state. Wanting to sleep fewer hours is not a disease state. Insomnia is, but wanting to just sleep fewer hours and be fully rested is not a disease s…”

“We've moved the drug development timeline, which the industry is about nine years, from first human dose to FDA approval. And when I started, ours was about 11. And now we're 6.1.”

“We have a submission document to get in and it used to be our standard was a 120 days from when you had the data to when you send it to the FDA. We're now doing that routinely inside of two weeks.”

“The Results Act says that if any pharmaceutical, any medical device is approved in another major developed country, so approved in Canada or Japan or the EU, That the FDA has 60 days to approve it here, or it's deemed automatically approved by operation.”

“So the microplastic problem is something that will certainly trigger A bunch of FDA review, a bunch of EPA review.”

“With the GLP-I example, for example, it's gonna come down to a 149 dollars for the first three months.”

“Which we announced this week. We are now going to allow Bayesian statistics to be used.”

“I sent out 1500 enforcement letters, including over a hundred cease and desist letters for ads that were creating a misleading impression, including online pharmacies that are advertising drugs without the same, ah side effects that pharma companies list when …”

“So we have basically said we have a thousand chemicals plus in the U.S. Food supply that do, are not allowed in other food system supplies.”

“And we announced just this week that we are getting rid of the, some of the regulatory requirements for cell and gene therapy.”

“We have, I think, 18 products that have vouchers for this new pilot program.”

“So we gave them a list that constitutes about 38 doses from age zero to 18.”

“We announced just last month that we are going to go from a baseline default requirement of two pivotal trials for a drug to one pivotal trial for a drug.”

“Our rejection letter is public, so that if the FDA does not approve a drug, the public deserves to know why.”

“And I have signed 100% of Right to Try requests that come across my desk.”

“We have announced 42 major reforms in my 10 months in office at the FDA.”

“These bespoke therapies, we created essentially a novel pathway for them. Dr. Vinay Prasad described it in the New England Journal of Medicine. It's called the plausible mechanism pathway, and it's basically combining gold standard science with common sense.”

“Within weeks of coming into office, we took action to remove all nine artificial petroleum-based dyes.”

“We're closing that loop. We're changing the regulation to close that loop.”

“The announcement that we made on Sunday was that we're going to customize the manufacturing requirements to the drug and the population being treated.”

“We are actually hiring 1050 new scientists because we have very ambitious goals on our new pathways, accelerated type pathways, and so we're building up capacity to have a whole new line of pathways so that we can deliver faster for the American people.”

“They're going to be deregulated, so you can give those results of any physiologic parameter, but if you say that it's a quote unquote medical grade blood pressure, then we are going to want to see the data to make sure that it's validated with the gold standar…”

“No scientific reviewer was laid off, but there were significant consolidations in HR, procurement, IT, and the duplicative services that were out there.”

“The Biden folks in the year before I came to the FDA sent out zero enforcement letters. A department of about 35 people in charge of sending out enforcement letters sent out zero enforcement letters.”

“And so we've said, we have to close the loophole on grass. We started the regulatory process to do that.”

“We have changed the requirements so that we use the same principles we use for small molecules If you are structurally the same as a small molecule branded drug, we're going to approve you with some other stipulations. And so we are reducing the cost of R&D of…”

“It took, and you know, some often still takes, 60 days just for the FDA to tell you that your application is complete. We're going to get that down to one day. We're going to use AI.”

“We did find that there was in the Biden administration approval to have the cells of Americans for CAR T therapy shipped to China where the Chinese did the gene editing and then shipped back to the United States. To infuse in Americans. When I found out about …”

“He's a co-founder of a company called Life Biosciences, and they've reached a major agreement with the FDA to be the first company to treat humans with Yamanaka factors.”

“That's what they're saying. Could happen sooner. I mean, the data's in, the, you know, the FDA will take their time to evaluate it, but I think given the way this is all looking, could happen sooner, could happen sometime later this year.”

“Because of the human biology and the FDA, if you find a compound, and you think you've got something, that's like five percent of the work.”

“Dario wrote a new blog post. Saying that transparency was no longer good enough, that we needed to have a new regulatory agency like an FAA or maybe an FDA to approve all models.”

“And then separately, a lot of biotech has moved offshore from the U S for the same reason that you're pointing out, which is the FDA approval cycle. Is so long and the stages slow people down so much and China's completely revamped their rules for getting to c…”

“Setting up a new AI Regulatory agency that operates like the FDA and takes years to approve new models. But in any event, I don't think that's gonna happen under President Trump.”