The Food and Drug Administration Amendments Act of 2007, FDAAA, authorized the FDA to institute REMS
for small-molecule drugs and biologies.
* If an aspect of the REMS
is covered by a patent or is a trade secret and the generic company was unable to obtain a license for use.
Voting to modify and strengthen the REMS
sends a very clear message, as the FDA's actions "do have a cascading effect," said Dr.
Workflow challenges have been costly because monitoring programs often require double and triple documentation, with redundant information added to medical charts, pharmacy records and the REMS
The centralized platform based on Microsoft Amalga UIS and HealthVault will provide an easy-to-use interface for physicians, pharmacists and patients involved in REMS
. It will also feature intuitive navigation and a high level of customization to provide clients greater control of their REMS
* First, the guidance says that a manufacturer may voluntarily submit a proposed REMS
"if the applicant believes an REMS
would be necessary to ensure that the benefits of the drug outweigh its risks." As a result, such submissions may come with an unintended admission by the manufacturer that, without the proposed REMS
, the drug's risks outweigh its benefits.
Only 34 out of 200 REMS
(17%) were actually imposed within the first year of the FDAAA legislation.
Patient education about the appropriate use of opioids as well as their risks was unanimously thought to be an important part of REMS
, but proposals were not consistent in how or where such education would take place.
Aserinsky and Kleitman (1) coined the term "REM
sleep" because of the presence of rapid eye movements during this unique phase of sleep while Dement (3) used the term "active sleep" to define the same state because the EEG pattern resembled that of an active awake state.
In the past, content analysis studies have examined trends of career development research in The Career Development Quarterly (CDQ) and the Journal of Vocational Behavior (JVB; Buboltz, Ebberwein, Watkins, & Savickas, 1995), REM
research in counseling (Carter, Akinsulure-Smith, Smailes, & Clauss, 1998; Perez, Constantine, & Gerard, 2000; Ponterotto, 1988), and career development research with REMs
(Byars & McCubbin, 2001; Hoyt, 1989; Koegel, Donin, Ponterotto, & Spitz, 1995).
These brain stem blasts zip to the frontal brain during periods of rapid eye movement (REM
) sleep, when the entire brain becomes nearly as active as when a person is awake.
In addition to the numerous scientific investigations of each concept separately, sleep, memory, and learning have been studied together to determine (a) the effect of sleep on memory and learning, (b) the effect of sleep deprivation in general on memory and learning, (c) the effect of rapid eye movement (REM
) sleep deprivation on memory and learning, (d) the effect of memory and learning on REM
sleep, and (e) the effect of non-REM sleep loss on memory and learning.