The Nutrition Facts Label on food packaging is an important and easy way to get essential information to help you make healthy food choices. These FDA Consumer Updates are also a great resource for more nutrition facts, and other helpful...
From medical X-ray scanners used to see inside the body to surgical lasers used for cosmetic purposes or to improve eyesight, FDA ensures the safety and effectiveness of a wide range or products that emit radiation. To learn more, read...
From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more.
Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
This page contains the meeting materials for the Antimicrobial Drugs Advisory Committee meetings for 2017, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions,...
This page contains the meeting materials for the Antimicrobial Drugs Advisory Committee meetings for 2017, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions,...
This page contains the meeting materials for the Antimicrobial Drugs Advisory Committee meetings for 2017, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions,...
This page contains the meeting materials for the Antimicrobial Drugs Advisory Committee meetings for 2019, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions,...
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect fees for biosimilar biological products from October 2017 through...
In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007.
A list of all FDA-approved abbreviated new drug applications for drug products that received a Competitive Generic Therapy designation under section 506H of the Federal Food, Drug, and Cosmetic Act.
Resources and information for requestors interested in CDER’s Clinical Outcome Assessments (COA) Qualification Program. This update contains the Letter of Intent Template for the COA Qualification Program, as described under section 507...
The Clinical Outcome Assessment (COA) Qualification program manages the qualification process for COAs intended to address unmet public health needs, works directly with requestors in guiding COA development for qualification.
Patient Listening Sessions led by FDA’s Office of Patient Affairs provide an opportunity for medical product Centers to engage with patients, caregivers, and advocates about their experiences and perspectives.
Patients today have more treatment options in the battle against coronavirus disease. FDA has approved one drug treatment for COVID-19 and authorized others for emergency use during this public health emergency.
FDA revised the emergency use authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together) authorizing REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19.
Just as FDA reviews drugs for humans for safety and effectiveness before they can go on the market, the agency does the same for treatments for animals. Learn how FDA brings new oncology treatments to market and questions to ask your vet...
Sunshine Mills, Inc. is issuing a voluntary recall of certain products due to potentially elevated levels of Aflatoxin above the acceptable limit. Aflatoxin is a naturally occurring by-product from the growth of Aspergillus flavus and...
FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes; Availability Will Help Increase Access and Potentially Lower the Cost of Insulin for People with Diabetes
FDA issued a warning letter to Visible Vapors LLC advising that marketing its tobacco products without premarket authorization, is illegal, and they can’t be sold or distributed in the U.S.
BrightFarms today initiated a voluntary recall expansion of additional packaged salad greens that are past expiration date and were produced in its Rochelle, Illinois (Ogle County) greenhouse farm sold in Illinois, Wisconsin, Iowa,...
The FDA has approved biosimilar medications to treat conditions such as cancer, diabetes, Crohn’s disease, colitis, rheumatoid arthritis, psoriasis, and more.
Whole Foods Market is voluntarily recalling Cahill Cheddar Porter and Whiskey Cheddar Cheeses from 44 stores across 22 states because of a potential contamination of Listeria monocytogenes.
McCormick & Company, Inc. is initiating a voluntary recall of McCormick Perfect Pinch Italian Seasoning, McCormick Culinary Italian Seasoning and Frank’s RedHot Buffalo Ranch Seasoning due to possible contamination with Salmonella....
Excalibur Seasoning Company of Pekin, IL is recalling 17 bottles of Haen Meats 1959 House Blend because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal...
Hyperbaric Oxygen Therapy (HBOT) devices only considered safe and effective for certain conditions. The FDA recommends you use a HBOT device under the care of a doctor and in a hospital or facility that has hyperbaric accreditation.
During the coronavirus pandemic, you've learned a lot about keeping your family safe. If your family includes pets, you want to keep them safe, too. FDA offers some helpful questions and answers about keeping your pets safe during...
Old Souls Farms, LLC, located at in St. Paris Ohio is initiating a voluntary recall of greenhouse leafy green products following a positive test of Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and...