Month: December 2014

Warning Letter for Wellmill LLC/DBA Vitamix Laboratories

The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located in 69 Mall Drive, Commack, New York from May 19 through May 30, 2014. During the inspection, our investigator found a number of serious violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, …

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FDA Approves Combo Hepatitis C Treatment

The U.S. Food and Drug Administration on Friday approved a new combination treatment for people with chronic hepatitis C virus infection, which can lead to advanced liver disease without treatment. The drug, Viekira Pak, includes a pill containing three antiviral drugs (ombitasvir, paritaprevir and ritonavir) along with a dasabuvir pill. All but ritonavir are new. …

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Ebola Response Reveals Double Standard In U.S. Health Care

Since Ebola was first discovered in 1976, there have been an estimated 16 to 22 recorded outbreaks. In August, the World Health Organization designated the most recent outbreak a global emergency. Ebola is a deadly infection and the scope of the current epidemic in West Africa is unprecedented. More than 17,000 people have contracted Ebola Virus Disease …

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FDA Warns Antipsychotic Drug May Cause Fatal Skin Reaction

The U.S. Food and Drug Administration issues a warning on Thursday that an antipsychotic drug manufactured by Pfizer could cause a potentially serious and life-threatening skin reaction. FDA said the antipsychotic drug, Geodon, and its generic versions can trigger a skin condition – known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). It said DRESS may start as a rash and could spread …

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Family of powdered caffeine-overdose victim meets with FDA and lawmakers in quest for regulation

WASHINGTON, D.C. – Sen. Sherrod Brown will meet today with families of two young men who died after overdosing on powdered caffeine, then will present a petition from the families and others to the federal government asking for the bulk powdered stimulant to be banned for retail sale. The family of Logan Stiner, an 18-year-old …

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ELECTRIC IMPLANTS KILL OFF INFECTIONS, THEN DISSOLVE

Someday, in the not-too-distant future, bacterial infections could be treated by implanting electronics into your body. A team from Tufts University and the University of Illinois at Champaign-Urbana developed a tiny implant that can be inserted into an area of infection (or potential infection) and activated remotely, delivering either heat or drugs to infected tissues, …

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Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug Substances

The authors re-examine environmental controls in the context of technical advances in manufacturing. The control of the environment around biologics manufacturing has historically been a key consideration for the design and operation of bioprocessing facilities to ensure product quality and safety. Facility design and control considerations for commercial biopharmaceutical manufacturing processes include environmental controls (e.g., …

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