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FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Finally, FDA plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
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Epigenomics submits the fourth module to the FDA for Epi proColon
Epigenomics AG announced that it has submitted the fourth and final module of its Premarket Approval (PMA) to the United States Food & Drug Administration (FDA) for its blood-based Epi proColon® test for the detection of colorectal cancer in December 2012 as previously indicated, thereby co ... more
FDA Approves Genzyme’s AUBAGIO (teriflunomide), a Treatment for Relapsing Multiple Sclerosis
Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration (FDA) has approved AUBAGIO® (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). AUBAGIO has shown significant efficacy across key measures ... more
Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted approval for tbo-filgrastim (XM02 filgrastim), the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the United States in more than 10 years. Tbo-filgrastim is ... more
U. S. Food and Drug Administration (FDA)
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public hea ... more
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