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.
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, in a memo to the center staff.
Frueh is Associate Director for Genomics, OCPB, CDER
will be responsible for the reviews.
The two-part CDER
Town Meeting is another highlight of the Annual Meeting.
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.