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FDA has issued 7 warning letters linked to 20+ violative products with concerns about GLP-1 and other products sold to consumers marked for “research purposes” or “not for human consumption”. These products may pose serious health risks. Do not use or purchase unapproved GLP-1 products marketed for research purposes.

FDA has issued 7 warning letters linked to 20+ violative products with concerns about GLP-1 and other products sold to consumers marked for “research purposes” or “not for human consumption”. These products may pose serious health risks. Do not use or purchase unapproved GLP-1 products marketed for research purposes.

1,382,150 Aufrufe

FDA proposes to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list. After careful review, we did not identify sufficient clinical need for outsourcing facilities to compound these drugs from bulk substances. Public comment period now open. Learn more:

FDA proposes to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list. After careful review, we did not identify sufficient clinical need for outsourcing facilities to compound these drugs from bulk substances. Public comment period now open. Learn more:

104,588 Aufrufe

The U.S. FDA has issued a "safe to proceed" letter allowing the initiation of an expanded access treatment protocol (EAP) for daraxonrasib, an experimental drug targeting pancreatic cancer. Per EAP guidelines, requests must be submitted to the sponsor by U.S.-licensed physicians on behalf of eligible patients. #FDA #PancreaticCancer

The U.S. FDA has issued a "safe to proceed" letter allowing the initiation of an expanded access treatment protocol (EAP) for daraxonrasib, an experimental drug targeting pancreatic cancer. Per EAP guidelines, requests must be submitted to the sponsor by U.S.-licensed physicians on behalf of eligible patients. #FDA #PancreaticCancer

50,617 Aufrufe

Today FDA approved the first-ever gene therapy for the treatment of genetic hearing loss under the National Priority Voucher Program. ✅6th approval under the National Priority Voucher Program ✅Approved 61 days after filing

Today FDA approved the first-ever gene therapy for the treatment of genetic hearing loss under the National Priority Voucher Program. ✅6th approval under the National Priority Voucher Program ✅Approved 61 days after filing

40,925 Aufrufe

Today, FDA approved a medication for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), to be used along with diet and exercise.

Today, FDA approved a medication for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), to be used along with diet and exercise.

71,841 Aufrufe

This Veterans Day, we thank all military veterans, including the many FDA employees who have served our nation.

This Veterans Day, we thank all military veterans, including the many FDA employees who have served our nation.

13,617 Aufrufe

#DrMartinLutherKingJr once said, "Of all the forms of inequality, injustice in health is the most shocking and inhumane.” The FDA remains committed to promote and protect the health of diverse populations through research and communication of science that address health disparities. Thank you, Dr. King, for your dream and commitment to equality for all.

#DrMartinLutherKingJr once said, "Of all the forms of inequality, injustice in health is the most shocking and inhumane.” The FDA remains committed to promote and protect the health of diverse populations through research and communication of science that address health disparities. Thank you, Dr. King, for your dream and commitment to equality for all.

20,417 Aufrufe

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Today, FDA provided important updates on the risk of myocarditis after receiving an mRNA COVID-19 vaccine, noting the risk is higher in young men.

Today, FDA provided important updates on the risk of myocarditis after receiving an mRNA COVID-19 vaccine, noting the risk is higher in young men.

1,895,688 Aufrufe • vor 11 Monaten

Today, the FDA launched Elsa, a generative AI tool designed to help employees—from scientific reviewers to investigators—work more efficiently. This innovative tool modernizes agency functions and leverages AI capabilities to better serve the American people. Elsa in Action ➤ Accelerate clinical protocol reviews ➤ Shorten the time needed for scientific evaluations ➤ Identify high-priority inspections targets ➤ Perform faster label comparisons ➤ Summarize adverse events to support safety profile assessments ➤ Generate code to help develop databases for nonclinical applications

474,431 Aufrufe • vor 1 Jahr

Today, the FDA announced its Commissioner’s National Priority Voucher program to accelerate the delivery of crucial treatments to the American public.

Today, the FDA announced its Commissioner’s National Priority Voucher program to accelerate the delivery of crucial treatments to the American public.

455,542 Aufrufe • vor 11 Monaten

FDA Commissioner Makary sits down for a conversation with the newly appointed director of the Center for Biologics Evaluation and Research (CBER) Dr. Vinayak “Vinay” Kashyap Prasad and Sanjula Jain-Nagpal, Associate Director of Policy & Research Strategy, Office of the Commissioner (OC). The trio talks about the current and future happenings at the FDA.

FDA Commissioner Makary sits down for a conversation with the newly appointed director of the Center for Biologics Evaluation and Research (CBER) Dr. Vinayak “Vinay” Kashyap Prasad and Sanjula Jain-Nagpal, Associate Director of Policy & Research Strategy, Office of the Commissioner (OC). The trio talks about the current and future happenings at the FDA.

461,590 Aufrufe • vor 1 Jahr

The FDA is moving at LIGHT SPEED ⚡️🇺🇸 ✅ Cutting red tape on BIOSIMILARS to lower costs for your family ✅ MAHA Mission for supplement safety ✅ STOPPING the Screwworm parasite ✅ 1K+ NEW JOBS for top scientists ✅ Launching AEMS to modernize safety and save taxpayer dollars

The FDA is moving at LIGHT SPEED ⚡️🇺🇸 ✅ Cutting red tape on BIOSIMILARS to lower costs for your family ✅ MAHA Mission for supplement safety ✅ STOPPING the Screwworm parasite ✅ 1K+ NEW JOBS for top scientists ✅ Launching AEMS to modernize safety and save taxpayer dollars

99,494 Aufrufe • vor 2 Monaten

In 2025, the FDA implemented an agenda of bold reforms. We made a lot of progress — and we're just getting started.

In 2025, the FDA implemented an agenda of bold reforms. We made a lot of progress — and we're just getting started.

136,312 Aufrufe • vor 5 Monaten

It’s time to tell people the truth about food.

It’s time to tell people the truth about food.

82,179 Aufrufe • vor 4 Monaten

FDA Commissioner Dr. Marty Makary talks about promising treatments in the pipeline and the innovations and breakthroughs he’d like to see in the future.

FDA Commissioner Dr. Marty Makary talks about promising treatments in the pipeline and the innovations and breakthroughs he’d like to see in the future.

145,606 Aufrufe • vor 10 Monaten

This year marks the FDA’s 120th year of service to this nation. Today, we unveil the FDA's first-ever official seal—a symbol of our unwavering commitment to you.

This year marks the FDA’s 120th year of service to this nation. Today, we unveil the FDA's first-ever official seal—a symbol of our unwavering commitment to you.

63,752 Aufrufe • vor 4 Monaten

Another busy week at FDA!

Another busy week at FDA!

39,077 Aufrufe • vor 2 Monaten

🔊 New FDA Direct! Dr. Marty Makary and Dr. Prasad discuss Dr. Pazdur’s outstanding track record, CDER-CBER collaboration, and this week’s big news on HRT.

🔊 New FDA Direct! Dr. Marty Makary and Dr. Prasad discuss Dr. Pazdur’s outstanding track record, CDER-CBER collaboration, and this week’s big news on HRT.

83,896 Aufrufe • vor 6 Monaten

In 2025 we tested 102 samples of honey for hidden sweeteners. Most honey passed the test—but even a small amount of fraud matters. We’re staying vigilant to protect the integrity of your food.

In 2025 we tested 102 samples of honey for hidden sweeteners. Most honey passed the test—but even a small amount of fraud matters. We’re staying vigilant to protect the integrity of your food.

24,575 Aufrufe • vor 1 Monat

FDA approved two new drugs for rare diseases this week! Learn more about these approvals and other good news:

FDA approved two new drugs for rare diseases this week! Learn more about these approvals and other good news:

30,237 Aufrufe • vor 2 Monaten

Today, we finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV.

Today, we finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV.

282,587 Aufrufe • vor 3 Jahren

Listen as FDA Commissioner Dr. Marty Makary discusses how the latest generation of AI was used to assist FDA with our first scientific product review.

Listen as FDA Commissioner Dr. Marty Makary discusses how the latest generation of AI was used to assist FDA with our first scientific product review.

109,324 Aufrufe • vor 1 Jahr

FDA CBER Director Vinayak Prasad and Dr. Marty Makary discuss an evidence-based approach to COVID-19 vaccination.

FDA CBER Director Vinayak Prasad and Dr. Marty Makary discuss an evidence-based approach to COVID-19 vaccination.

97,580 Aufrufe • vor 1 Jahr

FDA Commissioner Dr. Marty Makary with Secretary Kennedy, Jay Bhattacharya and DrOzCMS as President Donald J. Trump signs Executive Order to bring the prices Americans and taxpayers pay for prescription drugs in line with those paid by similar nations.

FDA Commissioner Dr. Marty Makary with Secretary Kennedy, Jay Bhattacharya and DrOzCMS as President Donald J. Trump signs Executive Order to bring the prices Americans and taxpayers pay for prescription drugs in line with those paid by similar nations.

97,175 Aufrufe • vor 1 Jahr

In our latest FDA Direct conversation, we dive into recent policy changes: • Updates on the Commissioner’s National Priority Voucher program • Review of certain clinical trials involving foreign labs • Dr. Marty Makary insights from the BIO Conference

In our latest FDA Direct conversation, we dive into recent policy changes: • Updates on the Commissioner’s National Priority Voucher program • Review of certain clinical trials involving foreign labs • Dr. Marty Makary insights from the BIO Conference

77,723 Aufrufe • vor 11 Monaten

An FDA spin on the Pete and Bobby Challenge - the MAHA Moms Strength Challenge, brought to you by Deputy Commissioner Sara Brenner. Tagging a few MAHA Moms to keep it going: Karoline Leavitt (Karoline Leavitt) Dorothy Fink (womenshealth.gov) Stephanie Haridopolos (U.S. Surgeon General) Tracie Lattimore (Department of War 🇺🇸)

An FDA spin on the Pete and Bobby Challenge - the MAHA Moms Strength Challenge, brought to you by Deputy Commissioner Sara Brenner. Tagging a few MAHA Moms to keep it going: Karoline Leavitt (Karoline Leavitt) Dorothy Fink (womenshealth.gov) Stephanie Haridopolos (U.S. Surgeon General) Tracie Lattimore (Department of War 🇺🇸)

60,168 Aufrufe • vor 8 Monaten

Today, we approved the first nasal spray for the emergency treatment of allergic reactions, including life-threatening anaphylaxis, in adult and pediatric patients who weigh at least 66 pounds.

Today, we approved the first nasal spray for the emergency treatment of allergic reactions, including life-threatening anaphylaxis, in adult and pediatric patients who weigh at least 66 pounds.

116,733 Aufrufe • vor 1 Jahr