The Federal Trade Commission has been an outspoken critic of REMS
misuse, and the FDA has lately become more outspoken about REMS
misuse and more proactive about preventing it, Brill notes in the report.
On the front end, manufacturers use REMS
to restrict the sale of drugs to keep them out of the hands of generic firms, which typically need about 5,000 doses to conduct bioequivalence and bioavailability studies, Dr.
The members were specifically tasked with addressing a number of questions, such as whether the current REMS
ensures safe use of ER/ LA opioid analgesics without unduly limiting patient access to medications or burdening the health care system, whether the scope of the current FDA blueprint for prescriber education for ER/ LA opioid analgesics should be broadened, and whether immediate-release formulations should be included in the REMS
, among other questions.
HP said that it will provide Applications Transformation and Integration Services to connect REMS
to the existing systems, transforming the KTZh infrastructure into one that is more modern and better equipped to analyze available information and help reduce energy use.
program is expanding at a rapid pace, from 60 medications requiring REMS
in 2009 to 130 in early 2011.
Both the NUVIGIL and PROVIGIL REMS
consist of a Medication Guide to inform patients about the potential risks associated with the use of these medications, a communication plan and a timetable for submission of assessments of the REMS
Patients or healthcare providers who do not comply with the REMS
will not be allowed to receive or prescribe (or administer) these drugs.
The robust solution will integrate PPD's strategic, scientific, operational and regulatory capabilities in designing and implementing comprehensive REMS
and risk management programs with Microsoft's strong global software development expertise.
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.
Title IX, Section 901 of this act authorizes the FDA, as of March 25, 2008, to require applicants--pharmaceuticals and biotechnology companies--to submit a proposed REMS
as a component of NDAs, ANDAs and BLAs.
In February, the FDA sent letters to 16 manufacturers of generic and branded extended-release and long-acting opioid transdermal patches, capsules, and tablets that required the products to have REMS
. Immediate-release opioids would not be subject to REMS
under the current proposal, although some groups represented at the meeting, such as the American Pain Society, called for REMS
for all types of opioids.
Ponto-medullary area and REM
sleep regulation : It was observed that even after isolation of the pons from other brain regions by rostral and caudal transections, the periodic episodes of REMs
and PGO spikes persisted, which in a normally behaving animal were seen only during REM