August 2015 - Asepticenclosures

FDA Warning Letters: Facility Problems, Unsafe Ingredients, Drug Residues

The latest batch of warning letters posted by the U.S. Food and Drug Administration (FDA) included one addressed to Frito-Lay Inc. of Plano, TX, concerning the “poor state of repair” of the company’s snack food manufacturing facility in Pulaski, TN. The letter stated that an investigator from FDA who inspected the facility on May 26 and 27, and June …

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FDA extends use of Promacta in young children with rare blood disorder

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The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these children when they have not achieved an appropriate response using other ITP …

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FDA Releases 18 Years of Isolate-Level Data for Common Gut Bacteria

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In a move to make its data more transparent and promote scientific research, the US Food and Drug Administration (FDA) is releasing 18 years of data on several bacteria, collected as part of the National Antimicrobial Resistance Monitoring System (NARMS). Background Health authorities are increasingly citing AMR as one of the most pressing threats to …

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Merck recalls Temodar and Temozolomide bottles

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Merck Sharp & Dohme of Whitehouse Station, N.J., is recalling about 276,000 bottles with cracked caps containing Temodar (Temozolomide) and Temozolomide (generic) capsules The cracked bottle can cause the child-resistant closure to be ineffective, allowing young children to gain unintended access to the capsules, posing a risk of poisoning. No incidents or injuries have been …

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Women May Have an FDA-Approved Drug to Treat the Most Common Sexual Dysfunction

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That’s been my credo over 40+ years of fighting for gender equity. And trust me, I’ve been outraged for nearly every minute of the past four decades. With all the basic rights women have had to fight tooth and nail to win and hang on to over that tumultuous period, how could I not? Next …

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FDA: We’re working to reduce the risks

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The FDA’s first priority is patient safety. The FDA has been working for several years to reduce the risk of patient infections associated with reusable endoscopes — small, flexible lighted tubes that allow doctors to see inside patients and treat certain medical conditions in a less invasive manner than traditional surgery. The devices, which include …

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Deadly harm: The result of regulatory failure by FDA

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On Monday, August 10, 2015 a young mother, Viviana Ruscitto, lay dying at a New York Hospital – her abdominal cavity filled with inoperable cancerous tumors blocking her intestines. Her toddler’s life was forever changed. You can read her account here. She was another apparent victim of a gynecological device, known as a “power morcellator”. …

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Court sides against FDA in “off-label” drug promotion case

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The maker of a prescription fish-oil pill won an early victory Friday against the Food and Drug Administration over its right to publicize unapproved uses of its drug. The preliminary ruling in U.S. District Court could strengthen the pharmaceutical industry’s ability to distribute information about drug uses that have not been cleared by the FDA. …

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Cuba’s medical breakthroughs have caught U.S. attention

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TAMPA — As relations with Cuba improve, many people in Tampa are hoping for easier access to one export item the island nation has made famous — premium cigars. But there’s far more at stake with another product developed in Cuba — a treatment for lung cancer, the disease most commonly caused by tobacco smoking. …

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Month: August 2015