Center for Drug Evaluation and Research

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Center for Drug Evaluation and Research

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CDER

A division of the U.S. Food and Drug Administration that reviews and oversees the manufacture of pharmaceuticals distributed to U.S. citizens and provides clinical information about the uses and hazards of drugs. Website: www.fda.gov/cder/
References in periodicals archive ?
L'AlgAaAaAeA@rie n'a pas d'autre ch se diriger vers des solutions environnementale et AaAaAeA@cologique [beauco plus grand que], conclue le DG du CDER.
Of all the items listed in Table 1, the researchers were particularly interested in how the CDER uses Warning Letters (WLs), since they are one of the stronger enforcement mechanisms.
CDER may call upon advisory committees to review submissions.
To ensure 2014's novel drugs get to patients as quickly as possible, CDER effectively employed a variety of regulatory tools including FDA's expedited development and review programs --fast track, priority review, accelerated approval and our new breakthrough therapy designation.
Furthermore, much can be learned by the CDER criteria for issuing WLs:
Among the biggest challenges facing CDER are a culture that is not supportive of staff, polarization between premarketing and postmarketing review staff, insufficient attention to scientific disagreement and a dearth of leadership, the report says.
The reorganization plans also call for elevating the status of the current Office of Drug Safety, which is primarily responsible for epidemiology and surveillance activities, and its staff will report to the CDER director.
Galson, CDER director, in a memo to the center staff.
Frueh is Associate Director for Genomics, OCPB, CDER, FDA.
Henceforth, CDER will be responsible for the reviews.
Signee en marge des journees portes ouvertes organisees par le CDER, cette convention a pour objectif de [beaucoup moins que] favoriser et d'initier le developpement de projets collaboratifs innovants dans un secteur en pleine expansion [beaucoup plus grand que], selon un communique de GE.