FDA

“That company alone has already gotten FDA approval to skip certain animal trials.”

“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.”

“It took a long time to get our FDA clearance. It, you know, it took almost two years longer than we initially expected.”

“As you mentioned, CAR-T, CAR-T was also approved in the same way as we believe Intesmiran will be, which is as a process BLA not a product BLA.”

“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…”

“And they issued a national recall. Right there and then. Issued a national recall of what was a pilot”

“So we had an investor come forward that we had spoken to in the past as well, and they ended up funding the business another four million dollars, which allowed us to spend the next 18 months, get our product off the line at this facility and into the FDA.”

“Small molecules are still 65% of FDA approved drugs, so we're talking about the biggest part of the pie.”

“We went too quickly, and we wanted to make a monolithic application. Mistake number one. Mistake number two, we picked a domain, which is perhaps the hardest of them all, which is health. Mistake number three, how many IBMers sell to doctors, and how many IBMe…”

“They are not FDA approved... They're all, you know, lack of evidence. They just, you know, Do something largely originating in Korea, China... It's business.”

“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.”

“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.”

“We were very fortunate to bring on a chief science officer last year who was a former chief scientist at the FDA for informatics and spent, Has spent a lot of his career focused on health data privacy and you know, issues around regulation with apps like this.”

“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.”

“Baby KJ was a baby who Add, I think it was a liver disorder or just, you know, at birth was identified with something that, that really was a horrible, horrible prognosis. And two scientists fast tracked with the FDA, like a one of one drug. So a drug that was…”

“Marty brought in an AI system to help them be able to comb through the thousands of pages of filings that sponsors behind medicines have to submit in record time versus the, you know, armies of people that would have to comb through that and the days and days …”

“Their new product, Stello, is the first over-the-counter FDA-approved CGM. This was just as of, like, last month end of August.”

“So Medvi received an FDA warning letter just two months ago for misbranding violations.”

“Lucy cannot make quit claims about the nicotine gum product. So even though most people think, oh, this is like Nicorette, it's actually regulated in a different category. It's regulated as tobacco product, not as a pharmaceutical product.”

“Taking Eretta Trutide, which is just sort of a GLP plus, if you will instead of just waiting it for it to be FDA approved, or like, Using Ozempic. I think this is like the worst risk reward decision you could possibly make.”

“I believe the FDA will make it legal to compound soon.”

“I think you can shut it down, and then I also think that we have a perfectly great system, which is the normal regulatory body we've had for 60 years. And creating, like I said, a new special ed version of it, For drugs that couldn't quite get on the school bu…”

“There's a very interesting drug that I think is going to become far more popular soon, which is already FDA approved called Sunosi, S-U-N-O-S-I, which is approved for excessive daytime sleepiness.”

“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.”

“I think that we will exceed them in value in many core areas. Because they, you, they can take, you know, well-structured, well-funded clinical trials. But then other things like peptides that are very promising. They're not going to have the clinical work.”

“Our biggest inhibitor and why we haven't done it yet is all the fees that the FDA charges. So it's about 365,000 dollars to set up what's called an end on new drug application.”

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

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

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

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

“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.”

“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 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.”

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

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

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

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

“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.”

“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.”

“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 …”

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

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

“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…”

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

“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.”

“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 …”

“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…”

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

“Since the birth of this industry, we only had increasing regulation over time. I think there was like only one time in history of biotech where we made it easier to develop and approve new drugs. And that was during the ACE crisis where AIDS patients were just…”

“Since then FDA started to require not just safety, but also efficacy in the approval process.”

“The Evandia one, we know well, we work in diabetes, actually caused a policy change, and the policy change was you must rule out cardiovascular risk prior to market entry, and as you may know some conditions like diabetes have a more continuous variable you're…”

“Personnel costs are not a giant aspect of America's budget, and arguably we need a lot more personnel in order to, you know, process drug discoveries and make the FDA much more efficient, Process high-skilled immigrant visas and have a much more functional gov…”

“There will be, yeah. So that's something that Dr. McCary, the FDA commissioner is working on. And there'll be also you know, changes in, in like how Medicare pays, Medicare, CMS, Medicare, and Medicaid pay for Leucovorin. So it's a cross-agency collaboration f…”

“We're actually the first modern brain computer interface company to have a FDA clearance. So the version of the electrode that you were holding in your hand actually has now FDA clearance. So among the current leading BCI companies, we're the only company that…”

“So very practically we write five to fifteen million dollar checks and seed and series a stage businesses healthcare technology, healthcare services The things we don't do is anything that requires FDA approval. So think med device, life sciences, biotech, tho…”

“It was made by Fresenius. The Fresenius CEO was in Austria. He brought it back with him to Boston. We gave it to my son, and four weeks later his hair started growing back, and his starvation, his albumin went from .2 to four. And he came home, and this was in…”

“And then kind of connected to that, we invested in another company in the advanced wound care space called Embed Biosciences. That's a synthetic skin that gets applied to wounds. It's really interesting. The FDA approved for two indications.”

“The FDA has issued marketing granted orders. These are MGOs. We'll get into this, but it's, like, slightly different than, like, FDA approval for a drug for the Juul system, recognizing that these products, as appropriate for the protection of public health, t…”

“Then they wind up splitting the company once both products are kind of taking off, but they're on very, very different trajectories. And it's very clear that They will be under very different regulatory regimes”