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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.

1,387,187 次观看

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:

105,664 次观看

The 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 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

55,896 次观看

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

41,611 次观看

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.

72,075 次观看

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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.

1,899,964 次观看 • 1 年前

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

474,941 次观看 • 1 年前

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.

455,858 次观看 • 1 年前

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.

462,855 次观看 • 1 年前

"We have the safest food supply in the world." – Acting Commissioner Deputy Commissioner Kyle Diamantas on CNBC. "Americans should feel confident in eating fresh produce including leafy greens at this point. FDA remains confident that all iceberg lettuce related to the cyclospora outbreak has been effectively removed from the market."

"We have the safest food supply in the world." – Acting Commissioner Deputy Commissioner Kyle Diamantas on CNBC. "Americans should feel confident in eating fresh produce including leafy greens at this point. FDA remains confident that all iceberg lettuce related to the cyclospora outbreak has been effectively removed from the market."

48,097 次观看 • 2 个月前

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

100,083 次观看 • 7 个月前

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.

282,649 次观看 • 3 年前

🔊 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.

84,100 次观看 • 11 个月前

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.

64,003 次观看 • 8 个月前

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.

116,969 次观看 • 2 年前

Another busy week at FDA!

Another busy week at FDA!

39,278 次观看 • 6 个月前

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:

30,434 次观看 • 6 个月前

"We want to focus the agency on cures and meaningful treatments." Dr. Marty Makary

"We want to focus the agency on cures and meaningful treatments." Dr. Marty Makary

46,118 次观看 • 1 年前

ICYMI: FDA announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply. Listen as FDA Commissioner Dr. Martin Makary discusses why this is critically needed in our country.

ICYMI: FDA announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply. Listen as FDA Commissioner Dr. Martin Makary discusses why this is critically needed in our country.

42,946 次观看 • 1 年前

Today’s FDA Direct focuses on 7-OH, a dangerous opioid found in candies, gummies, drink mixes, and even ice cream cones sold at vape shops across the country.

Today’s FDA Direct focuses on 7-OH, a dangerous opioid found in candies, gummies, drink mixes, and even ice cream cones sold at vape shops across the country.

35,892 次观看 • 1 年前

FDA issues draft guidance on integrating randomized controlled trials for drug and biological products into routine clinical practice.

FDA issues draft guidance on integrating randomized controlled trials for drug and biological products into routine clinical practice.

53,052 次观看 • 2 年前

7-OH is up to 13x more potent than morphine - yet it’s being sold openly across America. We are taking action to protect kids and prevent the fourth wave of the opioid epidemic. @WillCainShow_ Will Cain

7-OH is up to 13x more potent than morphine - yet it’s being sold openly across America. We are taking action to protect kids and prevent the fourth wave of the opioid epidemic. @WillCainShow_ Will Cain

32,669 次观看 • 1 年前

FDA Commissioner Dr. Marty Makary joined President Donald J. Trump and Secretary Kennedy at the MAHA Commission event this afternoon.

FDA Commissioner Dr. Marty Makary joined President Donald J. Trump and Secretary Kennedy at the MAHA Commission event this afternoon.

30,220 次观看 • 1 年前

For patients with severe Leukocyte Adhesion Deficiency Type I (LAD-I), treatment options have been limited. A new gene therapy may offer hope through the FDA’s accelerated approval pathway.

For patients with severe Leukocyte Adhesion Deficiency Type I (LAD-I), treatment options have been limited. A new gene therapy may offer hope through the FDA’s accelerated approval pathway.

10,387 次观看 • 6 个月前

Dr. Namandjé Bumpus, FDA's Chief Scientist, shares her story about speaking out against bias, breaking the glass ceiling, and helping guide the careers of others. #NMHM2023 Dr. Namandjé N. Bumpus

Dr. Namandjé Bumpus, FDA's Chief Scientist, shares her story about speaking out against bias, breaking the glass ceiling, and helping guide the careers of others. #NMHM2023 Dr. Namandjé N. Bumpus

23,230 次观看 • 3 年前