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Recently, we have identified a link between four listeriosis incidents/outbreaks to a variant of Listeria monocytogenes (Lm) serotype 4b strains, 4bV.
Laurel S. Burall+3 more
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System Safety In The News [PDF]
FDA Shuts Down Program that Allowed Medical Device Makers to Hide Reports of Malfunctions The United States Food and Drug Administration (FDA) recently announced that it is ending a decadeslong program that allowed medical device manufacturers to conceal
Muniak, Charles
core +2 more sources
Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling
The regulatory framework for considering the fetal effects of new drugs is limited. This is partially due to the fact that pediatric regulations (21 CFR subpart D) do not apply to the fetus, and only US Health and Human Service (HHS) regulations apply to
Dionna J. Green+4 more
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Opioids exert their analgesic effect by binding to the µ opioid receptor (MOR), which initiates a downstream signaling pathway, eventually inhibiting pain transmission in the spinal cord.
Jie Liu+7 more
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"The United States Food and Drug Administration: Its role, authority, history, harmonization activities, and cooperation with the European Union." [PDF]
The purpose of this article is to provide background about the United States Food and Drug Administration (FDA). The article will focus particularly upon the agency's authority, its place in the United States system, and its history as a domestic ...
Horton, Linda.
core
Food Safety and Security: What Tragedy Teaches Us about Our 100-Year-Old Food Laws [PDF]
The United States food safety system is antiquated and failing. The laws that form the foundation of our food protection and govern the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) were enacted over 100 years ...
DeWaal, Caroline S.
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Paired metagenomic and chemical evaluation of aflatoxin-contaminated dog kibble
IntroductionIdentification of chemical toxins from complex or highly processed foods can present ‘needle in the haystack’ challenges for chemists. Metagenomic data can be used to guide chemical toxicity evaluations by providing DNA-based description of ...
Andrea Ottesen+8 more
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Vibrio parahaemolyticus is a leading cause of seafood-borne infections in the US. This organism has a high genetic diversity that complicates identification of strain relatedness and epidemiological investigations.
Catharina H.M. Lüdeke+4 more
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\u3ci\u3eUnited States v. Caronia\u3c/i\u3e: Off-Label Drug Promotion and First Amendment Balancing [PDF]
Off-label drug promotion is commonplace in the United States, but it is not without its dangers. While the Food, Drug, and Cosmetic Act does not explicitly ban off-label promotion, the Food & Drug Administration (FDA)— in order to protect consumers from ...
Rabinowitz, Daniel P.
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The United States Food and Drugs Administration Approves a Generic Enoxaparin
The Food and Drug Administration (FDA) approved on July 23, 2010, the abbreviated new drug application (ANDA) by Sandoz Inc for a generic enoxaparin (Lovenox) as the FDA is satisfied with the active ingredient ‘‘sameness’’ and the interchangeability of Lovenox with this generic version.
openaire +3 more sources