References in periodicals archive ?
REMS are mandated by the FDA for certain high-risk pharmaceuticals.
The second draft guidance document, "Waivers of the Single Shared System REMS Requirement," describes the two circumstances under which the generic manufacturer can waive the single, shared REMS requirements:
PFL, said, " I recognize the unprecedented scale of the REMS....
Also, REMS will communicate real-time information to dispatchers, railway engineers and managers to enable them to respond to emerging challenges immediately.
Access is also impacted by REMS restrictions that limit prescribing to certain specialists or dispensing by specialty pharmacies, which make it difficult for hospitals to obtain needed medications and increase costs.
In accordance with the approved REMS, the company is currently updating NUVIGIL and PROVIGIL labelling to include the Medication Guide.
Whether we are working with clients to develop and manage REMS programs to assure safe use or developing a virtual training curriculum, this platform is an efficient solution to connect, manage and track all components of REMS programs."
This FDA guidance introduces the somewhat new concept of voluntary REMS submissions, whose mere existence could have a significant effect on future litigation.
To determine the need for a REMS, the FDA considers the following:
At the meeting, there appeared to be a clear majority viewpoint among those who spoke on various aspects of REMS for opioids.
As with most of the great discoveries in experimental science, the discovery of rapid eye movement (REM) sleep was more an act of serendipity than a concerted effort to look for something as complex and astonishing as REM sleep.
Given the importance of research in understanding the career development of REMs in educational and work settings, an overview of the research conducted in this area is essential.