REM

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According to the study, "Unrealized Savings from the Misuse of REMS and Non-REMS Barriers," yearly lost savings include $5.2 billion to the federal government and more than $1.8 billion in additional out-of-pocket costs for patients.

"We have seen REMS requirements exploited in two ways," FDA Commissioner Scott Gottlieb, MD, said in a statement.

Where will the trend to less REM metalwork and more electronics go next?

Committee members also stressed the need for underscoring the urgency of the matter throughout the process of modifying the REMS. The current REMS was approved in 2012 "to address the serious adverse outcomes of overdose, addiction, and death that result from long-standing problems of inappropriate prescribing, misuse, and abuse of these products," and the central component of the 2012 REMS is the availability of educational programs for prescribers, according to an FDA briefing document.

Temporary voting member of the Anesthetic and Analgesic Drug Products Advisory Committee, Elaine Morrato, Dr.PH., like each of the panelists, explained her reasoning for voting to modify the REMS, saying, "I recognize the unprecedented scale of the REMS.

Using the information available from REMS, which is designed to assist KTZh in reducing its energy usage, KTZh expects the potential savings to amount to 7% in electrical energy consumption and 13% in diesel fuel consumption.

The outcome of a 2010 FDA meeting regarding REMS revealed that the agency, pharmacists and providers currently agree on two things: (1) achieving the goals of the REMS program is vital; and (2) the program as it currently exists is confusing and costly and places too great a burden on those charged with carrying out its requirements.

25 October 2010 - US Cephalon Inc (NASDAQ: CEPH) said on Friday that the US Food and Drug Administration (FDA) has approved Risk Evaluation and Mitigation Strategies (REMS) for its medications NUVIGIL (armodafinil) Tablets [C-IV] and PROVIGIL (modafinil) Tablets [C-IV].

* Some EASUs require documentation by the facility or pharmacy of how they met the REMS requirements.

When completed, this first-of-its-kind technology solution will provide biopharmaceutical companies with a long-term system for managing operational components of REMS programs while tracking large amounts of information collected from multiple sources, including the patient, healthcare provider and pharmacy.

Under the Food and Drug Administration Amendments Act of 2007, the FDA can now require pharmaceutical companies to submit REMS prior to approval of certain drugs and biologics.