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Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

BACKGROUND: The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related...

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Autors principals: Nguyen, Diane, Seoane-Vazquez, Enrique, Rodriguez-Monguio, Rosa, Montagne, Michael
Format: Artigo
Idioma:Inglês
Publicat: BioMed Central 2013
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Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC3582490/
https://ncbi.nlm.nih.gov/pubmed/23339419
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1472-6963-13-27
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