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Ningbo Huize Commodity receives FDA warning for quality control failures
August 30, 2019
Ningbo Huize Commodity Company recently received a warning letter from the U.S. Food and Drug Administration over Current Good Manufacturing Practice (CGMP) violations.
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New study says The Real Cost smoking prevention program saves 587,000 youths from smoking
August 29, 2019
The Food and Drug Administration’s “The Real Cost” campaign prevents 587,000 youth from starting smoking and saves more than $53 billion, according to a new study in the American Journal of Preventive Medicine.
Read more →FDA reviews data manipulation in AveXis’ new gene therapy drug for children
August 25, 2019
One month after the approval of a new gene therapy drug for a rare disease in children, the Food and Drug Administration was informed by AveXis Inc., the product’s manufacturer, about a data manipulation issue.
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FDA warning about the side effects of Miracle Mineral Solution
August 25, 2019
The Miracle Mineral Solution has been a concern of the Food and Drug Administration since 2010. Once again, the FDA is warning people not to buy these products because, once the solution is mixed, it develops into a harmful bleach, causing a variety of serious and potentially life-threatening side effects.
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New cloud-based vital signs measurement system approved by FDA
August 24, 2019
The new Vital Signs Measurement System from DynoSense Corp. was approved by the Food and Drug Administration on Aug. 13.
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FDA to unveil new warning labels for cigarettes
August 24, 2019
The U.S. Food and Drug Administration is planning on unveiling a new rule where they will implement new health warnings in regard to cigarette packages.
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Some flavored e-liquid and hookah tobacco products to be removed
August 16, 2019
Warning letters were issued by the U.S. Food and Drug Administration to four companies who do not have the required marketing authorization for 44 flavors of e-liquid and hookah tobacco products.
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Dynacure receives orphan drug designation for drug to treat Centronuclear Myopathies
August 16, 2019
DYN101, an investigational antisense medication for Centronuclear Myopathies (CNM), has received Orphan Drug Designation, according to the drug development company Dynacure.
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Drug-patent reform seeks accessibility, less data
August 13, 2019
As prescription drugs remain inaccessible to most, the notion of patent reform is seemingly settling into public discourse.
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