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Dr. Marty Makary

@DrMakaryFDA • 57,841 subscribers

Official account of the 27th Commissioner of the @US_FDA Catch up with FDA Direct: https://t.co/QJ6g8bH7wc

Shorts

Doctors are hungry for data on Covid-19 boosters. If a 52-year-old, perfectly healthy patient came to me asking if they should get their fifth or sixth Covid booster, I wouldn’t have any evidence to inform a strong, educated recommendation. It’s been a guessing game.

Doctors are hungry for data on Covid-19 boosters. If a 52-year-old, perfectly healthy patient came to me asking if they should get their fifth or sixth Covid booster, I wouldn’t have any evidence to inform a strong, educated recommendation. It’s been a guessing game.

286,580 views

FDA is expanding its use of real world evidence.

FDA is expanding its use of real world evidence.

40,836 views

FDA rejection letters are now public — another FDA first. If the FDA rejects a drug, the public deserves to know why!

FDA rejection letters are now public — another FDA first. If the FDA rejects a drug, the public deserves to know why!

47,857 views

We’ve tolerated inaction on autism for far too long.

We’ve tolerated inaction on autism for far too long.

33,394 views

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A milestone day for clinical trial innovation. We’re announcing the first real-time clinical trials, where FDA can see data signals and endpoints in real time. A quick explainer:
2:20
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A milestone day for clinical trial innovation. We’re announcing the first real-time clinical trials, where FDA can see data signals and endpoints in real time. A quick explainer:

Dr. Marty Makary

431,684 views • 4 months ago

TWO DAYS after receiving the application, FDA greenlit the new pancreatic cancer drug daraxonrasib for expanded access. This drug has also been granted a national priority voucher, which means a full application could be reviewed in a matter of weeks instead of 10-12 months.
0:41
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TWO DAYS after receiving the application, FDA greenlit the new pancreatic cancer drug daraxonrasib for expanded access. This drug has also been granted a national priority voucher, which means a full application could be reviewed in a matter of weeks instead of 10-12 months.

Dr. Marty Makary

419,175 views • 4 months ago

FDA is now open to Bayesian statistical approaches. A leap forward! Bayesian statistics can help: ✅ Clinical trial design ✅ Finding the optimal dose ✅ Extrapolation to children ✅ Leveraging phase 2 results in phase 3
1:08
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FDA is now open to Bayesian statistical approaches. A leap forward! Bayesian statistics can help: ✅ Clinical trial design ✅ Finding the optimal dose ✅ Extrapolation to children ✅ Leveraging phase 2 results in phase 3

Dr. Marty Makary

653,389 views • 7 months ago

The potential benefits of hormone replacement therapy for women have been in the bucket of things that modern medicine has underappreciated, underrecognized, and underfunded. Women need to know the real data on this topic – not dogma.
1:23
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The potential benefits of hormone replacement therapy for women have been in the bucket of things that modern medicine has underappreciated, underrecognized, and underfunded. Women need to know the real data on this topic – not dogma.

Dr. Marty Makary

748,354 views • 1 year ago

When I got to the FDA, I was shocked to learn that we had been allowing Americans’ living cells to be shipped to labs in China for gene editing before being shipped back and infused into Americans – sometimes without the patients even knowing.
0:42
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When I got to the FDA, I was shocked to learn that we had been allowing Americans’ living cells to be shipped to labs in China for gene editing before being shipped back and infused into Americans – sometimes without the patients even knowing.

Dr. Marty Makary

744,068 views • 1 year ago

For far too long, we’ve watched an expanding autism epidemic with no good answers.
3:43
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For far too long, we’ve watched an expanding autism epidemic with no good answers.

Dr. Marty Makary

622,874 views • 11 months ago

Women live longer and feel better when they start Hormone Replacement Therapy within 10 years of the onset of menopause. Every woman needs to know about this and watch our FDA expert panel that just took place. Morning Joe
2:19
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Women live longer and feel better when they start Hormone Replacement Therapy within 10 years of the onset of menopause. Every woman needs to know about this and watch our FDA expert panel that just took place. Morning Joe

Dr. Marty Makary

715,120 views • 1 year ago

FDA is moving proactively to advance potential therapies to address America’s mental health crisis. It’s time for new approaches.
0:35
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FDA is moving proactively to advance potential therapies to address America’s mental health crisis. It’s time for new approaches.

Dr. Marty Makary

222,422 views • 4 months ago

FDA is moving with unprecedented agility. Today we approved a multiple myeloma drug just 55 days after the application was filed. And last week’s approval (a major leap forward) was approved in 44 days. If a trial result shows immediate promise for many Americans, why wait?
1:08
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FDA is moving with unprecedented agility. Today we approved a multiple myeloma drug just 55 days after the application was filed. And last week’s approval (a major leap forward) was approved in 44 days. If a trial result shows immediate promise for many Americans, why wait?

Dr. Marty Makary

272,597 views • 6 months ago

In France, the Covid shot is only recommended for people over age 80 and high-risk. In the UK, it's age 75 and high-risk. Beware of medical elites claiming absolute consensus when in fact the U.S. has been an international outlier.
0:27
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In France, the Covid shot is only recommended for people over age 80 and high-risk. In the UK, it's age 75 and high-risk. Beware of medical elites claiming absolute consensus when in fact the U.S. has been an international outlier.

Dr. Marty Makary

474,953 views • 1 year ago

Yesterday FDA approved a lung cancer drug just 44 days after filing. We're working at an "Operation Warp Speed" pace to fight cancer.
0:28
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Yesterday FDA approved a lung cancer drug just 44 days after filing. We're working at an "Operation Warp Speed" pace to fight cancer.

Dr. Marty Makary

258,315 views • 6 months ago

We’re cutting red tape on wearables for general wellness.
0:42
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We’re cutting red tape on wearables for general wellness.

Dr. Marty Makary

305,988 views • 8 months ago

Today we’re taking long-overdue action to rein in pharmaceutical ads. For too long, misleading ads have distorted the doctor-patient relationship and driven costly, inappropriate care. Our actions will encompass online pharmacies promoting drugs with no mention of side effects, and paid social media influencers advertising drugs.
1:21
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Today we’re taking long-overdue action to rein in pharmaceutical ads. For too long, misleading ads have distorted the doctor-patient relationship and driven costly, inappropriate care. Our actions will encompass online pharmacies promoting drugs with no mention of side effects, and paid social media influencers advertising drugs.

Dr. Marty Makary

436,431 views • 1 year ago

Casey Means is the right person for the job.
1:03
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Casey Means is the right person for the job.

Dr. Marty Makary

241,101 views • 6 months ago

Today, the FDA is taking action to remove concentrated ingestible fluoride prescription drug products for children from the market. A growing body of research is demonstrating how ingested fluoride can alter the gut microbiome. This is especially concerning with young children where the microbiome is in a critical state of development. When it comes to children, this FDA will always err on the side of safety.
1:24
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Today, the FDA is taking action to remove concentrated ingestible fluoride prescription drug products for children from the market. A growing body of research is demonstrating how ingested fluoride can alter the gut microbiome. This is especially concerning with young children where the microbiome is in a critical state of development. When it comes to children, this FDA will always err on the side of safety.

Dr. Marty Makary

523,163 views • 1 year ago

Happy to announce today regulatory flexibilities for cell and gene therapies. Patients and those working on cures deserve common sense approaches.
0:52
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Happy to announce today regulatory flexibilities for cell and gene therapies. Patients and those working on cures deserve common sense approaches.

Dr. Marty Makary

236,714 views • 7 months ago

FDA just completed the largest-ever testing of infant formula testing (covering 300 products), part of our broader approach to deliver for American families. 🍼 Rigorous testing and oversight 🍼 Re-evaluating nutrient requirements to allow for more innovative products 🍼 Building more secure supply chain
1:02
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FDA just completed the largest-ever testing of infant formula testing (covering 300 products), part of our broader approach to deliver for American families. 🍼 Rigorous testing and oversight 🍼 Re-evaluating nutrient requirements to allow for more innovative products 🍼 Building more secure supply chain

Dr. Marty Makary

130,372 views • 4 months ago

Today marks the beginning of the end of the government subsidization of diabetes and obesity.
4:15
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Today marks the beginning of the end of the government subsidization of diabetes and obesity.

Dr. Marty Makary

347,650 views • 1 year ago

Three large-scale studies have tried to prove a link between saturated fat and heart disease. None found an association.
1:17
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Three large-scale studies have tried to prove a link between saturated fat and heart disease. None found an association.

Dr. Marty Makary

208,211 views • 7 months ago

The FDA just approved three food colors – from natural sources – to use in foods and drinks. This means food manufacturers will have more options to safely add color to their products. Just as parents already do, FDA is putting the health of kids first. Stay tuned for more on this, and other efforts, as we all work to help make America Healthy Again.
1:07
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The FDA just approved three food colors – from natural sources – to use in foods and drinks. This means food manufacturers will have more options to safely add color to their products. Just as parents already do, FDA is putting the health of kids first. Stay tuned for more on this, and other efforts, as we all work to help make America Healthy Again.

Dr. Marty Makary

393,967 views • 1 year ago