"A significant minority of drugs that have been approved by FDA have been approved over the FDA's own medical reviewers' objections on safety grounds."
"The pharmaceutical industry finances about 75% of the FDA's drug division."
"Fentanyl is FDA approved. Most people don't know this."
"No federal judge has ever revoked FDA approval for a drug before."
"The reality is that there are serious reforms that have to be done at the FDA, and this administration is not going to do it."
"We're just days away from authorization from the FDA."
"The FDA is nowhere built to handle... true democratization of [technology]... ongoing survival of our species... not compatible."
"FDA's responsibility to the American people is to ensure that products are safe and effective."
"There may not be a more important issue at the Food and Drug Administration than the pandemic."
"FDA settles Ivermectin case, agrees to remove controversial social media posts."
"Americans should rejoice that we got the FDA to get out of the practice of medicine."
"A second booster for anyone 50 years and older from the FDA is coming soon."
"Purdue comes in big Pharma they hire all these marketers to go out and pitch their drugs that are non-addictive FDA approves on this and and you know pushes all these doctors to now start prescribing to Billy Billy's The Varsity High School."
"Approval would, of course, be through the FDA and they have a rigorous and thorough process for doing that."
"The FDA's conclusion: 'Tretinoin cream does not eliminate wrinkles, repair sun-damaged skin, reverse photoaging, or restore more youthful skin.'"
"The benefits of a single boosted dose outweigh the risks." - FDA
"Inhibit case Therapeutics announces FDA Has Lifted a full clinical hold on its multiple systems atrophy." - Steve Van Meter
"Arthur Hayes might not look like much, but he would go down in history as one of the most corrupt FDA commissioners of all time."
"FDA approvals are the mother of all catalyst plays."
"The good news is this was allowed by the FDA to go to clinical trials."
"Think about how great FDA is, it actually works bro."
"For peace of mind, this carrageenan is also recognized as safe by the Food & Drug Administration, the FDA."
"The FDA approving a new drug to treat Alzheimer's."
"This year, the FDA approved a drug that costs nearly $3 million."
"The FDA expected within hours to green light boosters for all adults."
"It's all about the money so the FDA is getting paid off by a lot of these companies."
"We've done it while maintaining the FDA gold standard for safety."
"MoCRA is the most significant expansion of the FDA's authority to regulate products since 1938."
"The FDA has approved the drug used for anti-depression to help people quit smoking cigarettes."
"The report led the United States to give actual regulatory power to the Food and Drug Administration."
"We have done wonders with the FDA. I want to thank the FDA and all of the great people there, and Dr. Hahn. But we have phase three trials already going on which is most people would have said impossible to even think about."
"Listen, I work with FDA. I consult for them. I know what they really think of the industry. They're very much think that we're arrogant, we think we know it all, we like to show off."
"Food is medicine, yep, the problem is there's so much [ __ ] food that the FDA passes for us."
"So, what is a cosmetic exactly? The FDA defines cosmetics as products for cleansing, beautifying, promoting attractiveness, or altering the appearance."
"One common thread with all these medications is that they're different from the existing FDA-approved medications."
"A statistically significant difference is all I need for the FDA to approve my treatment. False, you need to show not only that there are statistically significant results but they also the result is clinically significant."
"FDA is approving too much [ __ ] because now, because now you already know, you get these transfusions and you start looking at drugs, oh my God."
"We've had people go to Thailand and get fecal transplants because they had the money to do it, unfortunately there's a lot of pressure on the FDA from the drug companies who finance the FDA to not allow this to go forward."
"...the first prophylactic vaccine against cancer has been developed and approved by the FDA."
"We are aware that members of the media are anxious to speak with FDA about those proceedings, however, FDA will refrain from discussing the details of this meeting with media until its conclusion."
"FDA encourages all participants to advise the committee of any financial relationships that they may have regarding topics that could be affected by the committee's discussions."
"America's FDA admits on its website that the terms 'cruelty-free' and 'not tested on animals' have no legal definitions."
"So the FDA has approved PD-1 inhibitors for anyone that has high tumor mutation burden or microsatellite instability. Doesn't matter what the cancer is."
"The FDA wants to see clinical outcomes improve function for the patient and reduce mortality."
"Any time is really a good time during your drug development program to communicate with the FDA."
"The FDA approved very recently October 2022 based on Himalaya trial."
"The FDA and other international regulators have partnered to share information, coordinate inspection efforts, communicate on analytical methods, and develop rapid solutions to ensure the safety and quality of the drug supply."
"The FDA is really leaning in to learn and understand uh how AI could be used and how they need to be responsibly involved in regulating the application of AI."
"Off-label use refers to a drug being used for conditions other than those it was originally approved for by the FDA."
"The FDA approves Aldera for the treatment of actinic keratosis, squamous cell carcinoma, and basal cell carcinomas."
"Every drug approved by the FDA was in some way based on biomedical research funded by the NIH."
"...getting FDA approval is always a pain in the ass, but if you can get something to where you have people with money who are buying it for recovery and stuff, it just helps accelerate the science..."
"FDA is and will be prepared to effectively and quickly certify moving out safe products onto shelf."
"Risk management is in design validation in the FDA regulations because it is part of the work that you do to demonstrate that your device is safe and effective."
"He also has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices, and generic drugs."
"They are called FDA's three major regulations: GMP, GLP, GCP."
"These electronic records apply to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth by the FDA regulations."
"FDA warnings are not always based on complete epidemiological studies that really answer issues of causation."
"It's FDA approved for depression, generalized anxiety disorder, social anxiety disorder, panic disorder, separation anxiety disorder."
"If the FDA knocks on our door a few years from now and says, 'You got a hundred thousand people that have had this treatment,' we'll ask for approval at that point, but we'll have data for a hundred thousand people, so we should easily get the approval."
"The U.S. Food and Drug Administration (FDA) created a regulation that establishes current good manufacturing practices (CGMPs) for the food industry."
"The FDA approved a patch that prevents nausea."
"CBD has been approved by the FDA last year for treatment of two rare epilepsy disorders in infants."
"Neuralink just announced a few days ago that it is now authorized by the FDA to do human trials."
"FDA approved new breakthrough treatments for cancer, diabetes, and even vision loss."
"The FDA regulates IVDs as medical devices."
"Familiarize yourself with the definition of a medical device as well as how to search the FDA's public product classification database."
"The drug I've been working on for the past five years just got approved by the FDA."
"If we receive FDA marketing authorization, we believe private insurers will be similarly open to covering the procedure."
"The FDA is really focused on safety and efficacy... we are very programmable as humans."
"The every estrogen that I would prescribe you from the FDA or from an FDA approved source is bioidentical."
"The FDA is responsible for protecting the public health by assuring the safety and security of human and veterinary drugs."
"FDA warns popular pain relief creams may pose dangerous health risks."
"If you are going to use a product containing local anesthetics, the FDA recommends not using anything containing more than 4% lidocaine."
"FDA approvals are sort of the mother of all catalysts, especially for biotech plays."
"These are actually medical leeches, and they are FDA approved."
"There are no medications with an official indication for fibromyalgia now, that doesn't mean that things don't work, it just means that companies have not yet gotten approval from the FDA."
"Iron oxide nanoparticle is already approved by the FDA."
"The FDA has approved this device for clinical trials."
"Where can I go to find out more about mesh? There is a very good and concise summary that can be found at the FDA website."
"The FDA defines high frequency ventilators as any machine that delivers a rate of above 150 breaths a minute."
"If you take an FDA-approved medication, you know its efficacy has been well established."
"So I have some news there on that MGL move, MDGL, this one getting FDA approval for new drug approval here for its res diff drug."
"I hope that lawsuit just makes the FDA just get off their butts and just please, just do their due diligence."