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Dr. Marty Makary

@DrMakaryFDA • 58,225 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 Aufrufe

FDA is expanding its use of real world evidence.

FDA is expanding its use of real world evidence.

40,836 Aufrufe

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 Aufrufe

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

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

33,394 Aufrufe

Videos

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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.

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

416,245 Aufrufe • vor 2 Monaten

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

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

Dr. Marty Makary

430,857 Aufrufe • vor 2 Monaten

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

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

652,715 Aufrufe • vor 6 Monaten

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

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

Dr. Marty Makary

222,161 Aufrufe • vor 3 Monaten

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

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

Dr. Marty Makary

622,874 Aufrufe • vor 10 Monaten

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.

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

748,104 Aufrufe • vor 1 Jahr

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.

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

743,799 Aufrufe • vor 1 Jahr

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

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

714,677 Aufrufe • vor 1 Jahr

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?

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

272,146 Aufrufe • vor 4 Monaten

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

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

258,109 Aufrufe • vor 4 Monaten

Casey Means is the right person for the job.

Casey Means is the right person for the job.

Dr. Marty Makary

240,895 Aufrufe • vor 4 Monaten

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

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

Dr. Marty Makary

305,988 Aufrufe • vor 6 Monaten

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.

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

474,561 Aufrufe • vor 10 Monaten

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

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

130,217 Aufrufe • vor 2 Monaten

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.

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

436,401 Aufrufe • vor 10 Monaten

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.

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

523,020 Aufrufe • vor 1 Jahr

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

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

Dr. Marty Makary

236,511 Aufrufe • vor 6 Monaten

The FDA is on the HUNT for promising therapies.

The FDA is on the HUNT for promising therapies.

Dr. Marty Makary

110,730 Aufrufe • vor 3 Monaten

FDA is setting new records in how rapid we are approving cancer drugs—some are so powerful, they have the potential to bring patients out of hospice.

FDA is setting new records in how rapid we are approving cancer drugs—some are so powerful, they have the potential to bring patients out of hospice.

Dr. Marty Makary

152,744 Aufrufe • vor 4 Monaten

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

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

Dr. Marty Makary

208,010 Aufrufe • vor 6 Monaten