To meet these commitments, FDA in 2013 held a public stakeholder meeting to standardize REMS
, followed by an expert workshop which evaluated "current approaches in the design, development, implementation, and assessment of REMS
, limitations of existing methods for the design of REMS
programs, and existing approaches to identify, evaluate, and mitigate risks that can inform REMS
program is designed to reduce the risk of misuse, abuse, addiction, and overdose.
Development of REMS
is completed independently by each manufacturer and submitted to the FDA.
Most respondents said it is virtually impossible to measure the benefits of a REMS
compared to its burdens on patient access and cost of health care delivery for a newly approved drug and that, even for an already approved drug, it would likely require two years or more to effectively conduct such an assessment," asserts Milne.
The company added that the goal of each REMS
is to inform healthcare providers, patients and caregivers about the risks associated with these medications, including serious skin rash and hypersensitivity reactions.
Some EASUs require documentation by the facility or pharmacy of how they met the REMS
Efficient, effective REMS
programs require real-time access to information by multiple internal and external stakeholders," said Mike Wilkinson, executive vice president and chief information officer for PPD.
Depending on the nature of the risk associated with a given drug or biologic, the FDA may require that the REMS
contain various elements to communicate the drug's risks to health care professionals and the public.
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
-ON neurons fire during REM
sleep whereas REM
-OFF neurons stop firing during REM
Nelson concedes that he doesn't believe REM
intrusion will turn out to be the whole explanation for the near death experience.