Dr. Marty Makary

Official account of the 27th Commissioner of the @US_FDA

Catch up with FDA Direct:

[Dr. Marty Makary @DrMakaryFDA]

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 @DrMakaryFDA]

Pregnant women shouldn't be left guessing about how approved drugs could affect their pregnancy.

Our new FDA guidance is designed to help close that information gap.

[U.S. FDA @US_FDA]

The FDA is helping improve how safety data is collected for drugs & biologics used during pregnancy. Pregnant patients & their providers deserve clear, reliable information to make informed treatment decisions — and this final guidance is a step in the right direction. https://t.co/0XBRA52KnA

[Dr. Marty Makary @DrMakaryFDA]

A big improvement to FDA’s inspection toolkit.

[Dr. Marty Makary @DrMakaryFDA]

People in healthcare are not afraid of hard work—in fact, they love it. It’s tedious tasks THAT DON’T MATTER that drive burnout.

[Dr. Marty Makary @DrMakaryFDA]

Common sense health reforms can unite our country.

[Dr. Marty Makary @DrMakaryFDA]

Proud moment for the FDA—the first real-time clinical trial!

[Dr. Marty Makary @DrMakaryFDA]

Patients deserve a sense of urgency.

[Dr. Marty Makary @DrMakaryFDA]

We’re deeply committed to reforming our IND/Phase 1 process.

We must retain our position as the world leader in biotech.

[Dr. Marty Makary @DrMakaryFDA]

FDA is investing in its scientific community.

[Dr. Marty Makary @DrMakaryFDA]

American kids deserve healthier food — not an avalanche of drugs to manage symptoms.

[CBS News @CBSNews]

The FDA said it will allow some pancreatic cancer patients to receive access to a promising drug, even before it is officially approved. https://t.co/vB6lQzijPr

[Dr. Marty Makary @DrMakaryFDA]

Great to be among fellow surgeons at @AANSNeuro.

FDA is working hard to accelerate game-changing treatments and put the best tools possible in the hands of neurosurgeons.

[Dr. Marty Makary @DrMakaryFDA]

Thank you American Association of Neurological Surgeons!!

[The Yang Lab @TheYangLab1]

An outstanding session with @DrMakaryFDA @US_FDA @HopkinsMedicine and @DrAlexKhalessi @UCSDNeuroSurg @AANSNeuro @AANSDiversity @NSTumorSection #aans2026 #aans #Innovation #Collaboration #Transformation.

Congratulations to @DrMakaryFDA on receiving the Charles Plante Lecture Award!

@IsaacYangMD @UCLANsgy @UCLA_ENT @UCLAHealth @dgsomucla @HarborUCLA @HarborUCLASurg @HarborTrauma

[Dr. Marty Makary @DrMakaryFDA]

Great to visit with the Medical Device Manufacturers Association this morning! MDUFA negotiations have gone extremely well.

[Dr. Marty Makary @DrMakaryFDA]

Read more: https://t.co/eSZ3JxHG4q

[Dr. Marty Makary @DrMakaryFDA]

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 @DrMakaryFDA]

Experts agree: real-time clinical trials could have a major impact on accelerating cures.

Thank you to Dr. Meagher and Dr. Litton for joining us!

[Dr. Marty Makary @DrMakaryFDA]

45% of drug development time is “dead time”—where no clinical trial is in progress. We can do better.
https://t.co/Wau3rBfNYZ

[Dr. Marty Makary @DrMakaryFDA]

Learn more: https://t.co/hqMdUmqUah

[Dr. Marty Makary @DrMakaryFDA]

Real-time clinical trials could fundamentally transform the clinical trial landscape.