Press Releases on May 14, 2016 - EIN Presswire - Press Release Distribution Service

Published on May 14, 2016 - 06:01 GMT

FDA allows use of investigational test to screen blood donations for Zika virus

Español The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 14, 2016 - 06:00 GMT

FDA launches first ad campaign focused on dangers of smokeless tobacco among rural teens

Español The U.S. Food and Drug Administration announced today it is expanding its award-winning “The Real Cost” campaign to educate rural, white male teenagers about the negative health consequences associated with smokeless tobacco use. For the first time …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 14, 2016 - 06:00 GMT

FDA approves folic acid fortification of corn masa flour

Español The U.S. Food and Drug Administration today approved folic acid fortification of corn masa flour. The approval allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour, consistent with the levels of …

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Published on May 14, 2016 - 06:00 GMT

FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality

The U.S. Food and Drug Administration today approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior …

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Published on May 14, 2016 - 06:01 GMT

FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns

Today, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) took the first step toward rescinding its approval of the use of carbadox to treat swine because the drug may leave trace amounts of a carcinogenic residue. CVM’s action …

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Published on May 14, 2016 - 06:01 GMT

FDA allows marketing of first-of-kind tissue containment system for use with certain laparoscopic power morcellators in select ...

The U.S. Food and Drug Administration today permitted the marketing of PneumoLiner, the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer. Although the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 14, 2016 - 06:01 GMT

FDA approves first leadless pacemaker to treat heart rhythm disorders

The U.S. Food and Drug Administration today approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While the Micra Transcatheter Pacing System works …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 14, 2016 - 06:01 GMT

FDA approves Inflectra, a biosimilar to Remicade

Español The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra is biosimilar to Janssen …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 14, 2016 - 06:01 GMT

FDA releases final rule to ensure food safety during transport

Español 简体中文中國傳統日本 Français The U.S. Food and Drug Administration today finalized a new food safety rule under the landmark FDA Food Safety Modernization Act (FSMA) that will help to prevent food contamination during transportation. The rule will require …

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Published on May 14, 2016 - 06:01 GMT

FDA proposes limit for inorganic arsenic in infant rice cereal

Español The U.S. Food and Drug Administration is taking steps to reduce inorganic arsenic in infant rice cereal, a leading source of arsenic exposure in infants. Relative to body weight, rice intake for infants, primarily through infant rice cereal, is …

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Published on May 14, 2016 - 06:01 GMT

FDA approves first treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow

The U.S. Food and Drug Administration today approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a stem cell transplant from …

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Published on May 14, 2016 - 06:00 GMT

FDA reminds health care professionals not to use drug products intended to be sterile from Medaus

The U.S. Food and Drug Administration is reminding health care professionals and patients not to use drugs intended to be sterile that were produced by Medaus Inc., due to lack of sterility assurance. The FDA has issued a formal request to the Birmingham, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 14, 2016 - 06:00 GMT

FDA launches public education campaign to prevent and reduce tobacco use among LGBT young adults

Español The U.S. Food and Drug Administration today announced the launch of a historic public education campaign aimed at preventing and reducing tobacco use among lesbian, gay, bisexual and transgender (LGBT) young adults ages 18-24. Of the more than 2 …

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Published on May 14, 2016 - 06:00 GMT

Federal judge enters order of permanent injunction against Paul W. Franck

The U.S. Food and Drug Administration today announced that U.S. District Judge Carlos E. Mendoza entered an order of permanent injunction against Paul W. Franck of Ocala, Florida. According to the complaint filed with the consent decree, Franck …

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Published on May 14, 2016 - 06:00 GMT

FDA proposes ban on electrical stimulation devices intended to treat self-injurious or aggressive behavior

The U.S. Food and Drug Administration today announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health that cannot be corrected …

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Published on May 14, 2016 - 06:00 GMT

FDA issues rule for data collection of antimicrobial sales and distribution by animal species

The U.S. Food and Drug Administration finalized a rule today that revises its annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in animals intended for human consumption or food-producing animals. Companies …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 14, 2016 - 06:00 GMT

FDA takes significant steps to protect Americans from dangers of tobacco through new regulation

en español Today, the U.S. Food and Drug Administration finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic rule helps implement the bipartisan …

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Published on May 14, 2016 - 06:00 GMT

Federal court orders rice noodle company to stop selling products until it complies with food safety regulations

On April 27, 2016, the United States District Court for the Northern District of California entered a consent decree of permanent injunction against Kun Wo Food Products Inc., located in San Francisco, and its co-owners, Zi Xing Liu and Zi Chen Liu (“Kun …

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Published on May 14, 2016 - 06:00 GMT

FDA approves first drug to treat hallucinations and delusions associated with Parkinson’s disease

The U.S. Food and Drug Administration today approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease. Hallucinations or delusions …

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Published on May 14, 2016 - 06:00 GMT

FDA approves first generic Crestor

The U.S. Food and Drug Administration today approved the first generic version of Crestor (rosuvastatin calcium) tablets for the following uses: in combination with diet for the treatment of high triglycerides (hypertriglyceridemia) in adults; in …

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