Jul 22, 2010 . The American Academy of Physician Assistants (AAPA) is the only national organization that represents Physician Assistants (PAs) in all .

Apr 21, 2011 . By William T. Koustas – On Tuesday, April 19, 2011, after .

Is a REMS Request From FDA More Likely For Drugs and Biologics Indicated for Pediatric Use? Are REMS (Risk Evaluation and Mitigation Strategies) more .

Jun 8, 2011 . BioDelivery Sciences International is trying to change FDA restrictions on its drug that competitors don't face. Read about why there is a .

by S Jeffrey

Improving the FDA's REMS Program. The FDA recently concluded meetings reviewing industry, patient, and provider concerns surrounding the implementation of .

FDA Guidance on REMS and software solutions from Dyadem.

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FDA, U S Food and Drug Administration. Enter Search terms .

The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from .

Feb 17, 2010 . Amgen Inc. and Centocor Ortho Biotech Products, L.P., today announced that the U.S. Food and Drug Administration (FDA) has approved the Risk .

Aug 3, 2010 . While hearings held the previous week on REMS for opioid drugs revolved around how much more FDA needed to do, those speaking on the REMS .

Prescription drug abuse has become a major public health issue with increasing attention from media, community outcry, and government agencies.1,2 .

May 5, 2011 . As part of the Obama Administration's initiative aimed at reducing harm from opioids, the FDA has unveiled a strategy focusing on education.

Jul 28, 2010 . REMS. Risk evaluation and mitigation strategies are increasingly being used used on prescription drugs and the FDA wants drug companies to .

Aug 18, 2010 . FDA's Draft Risk Evaluation and Mitigation Strategy (REMS) Guidance – A Preliminary Review (Part II) On September 30th, FDA issued its long .

May 18, 2011 . FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now .

Jul 24, 2010 . The REMS would also have required manufacturers to provide FDA-approved patient education sheets for physicians to use in their interactions .

Apr 19, 2011 . Covidien Supports FDA on Long-Acting Opioid REMS Covidien (NYSE: COV), a leading global provider of healthcare products,

by A Gandey

Jul 27, 2010 . How stringent should the requirements be for drugs with safety concerns?

As a part of this charge, FDA is working with the pharmaceutical industry and stakeholders to develop REMS for certain classes of medication, .

Opioids and how the new FDA REMS may impact hospice patients.

by A Gandey

The new Risk Evaluation and Mitigation Strategy (REMS) is part of a larger . But, abuse and misuse is also extensive, with the FDA estimating that 33 .

Feb 10, 2009 . Since REMS became part of the FDA's duties, it seems that the agency and manufacturers have struggled with the concept, particularly as it .

8 posts - 7 authors - Last post: May 22FDA approves REMS for Nuvigil, Provigil. Full story: Drug Store News. FRAZER,A Pa. The Food and Drug Administration has approved risk .

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Apr 25, 2011 . This past week, the White House “unveiled a multi-agency plan aimed at reducing the “epidemic” of prescription drug abuse in the .

Dec 19, 2008 . In short, REMS is the process by which the FDA is going to require the establishment of effective post-marketing surveillance of all adverse .

Feb 16, 2010 . WASHINGTON -- The FDA has announced a formal strategy to reduce the risks of erythropoiesis-stimulating agents (ESAs) for cancer patients .

When concern about a serious risk of a drug or biological product may be related to the pharmacologic class of that product, the FDA may require a REMS to .

Apr 21, 2009 . The class-wide opioid Risk Evaluation and Mitigation Strategy should include a certification process for prescribers, pharmacists and other .

May 18, 2011 . Washington, DC - The FDA has come through with a risk evaluation and mitigation strategy (REMS) for the use of rosiglitazone (Avandia, .

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According to the FDA, the REMS are a way to manage known or potential serious risks associated with a drug or biological product. .

Mar 26, 2008 . FDA had 180 days as of the day FDAAA was enacted for the REMS provisions to take effect—March 26. The March 26 notice in the Federal .

Oct 8, 2009 . The FDA can require risk evaluation and mitigation strategies for certain prescription drugs and biological products, to ensure that the .

Biotrak provides drug safety and leading edge in REMS Assessments, pharmaceutical risk management, Observational research, Observational research studies, .

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Jan 13, 2011 . For the past couple of years, the FDA safety program known as the Risk Evaluation and Mitigation Strategies, or REMS, has been all the rage. .

Apr 19, 2011 . ST. LOUIS--(BUSINESS WIRE)-- Covidien (NYSE:COV - News), a leading global provider of healthcare products,

Mar 5, 2009 . By William T. Koustas – As we have previously reported, Title IX of the Food and Drug Administration Amendments Act of 2007 (“FDAAA” or “the .

Jun 13, 2011 . Reminder: Victoza not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise.

May 20, 2008 . A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the .

Sep 3, 2010 . As FDA has taken steps to implement the REMS provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), some stakeholders have raised .

Apr 20, 2011 . Part of the plan was the long-awaited FDA-backed Risk Evaluation and Mitigation Strategy, or REMS, focusing on reducing the misprescribing, .

Apr 20, 2011 . With many of their proposed changes ignored, critics of the FDA's risk evaluation and mitigation strategy (REMS) for long-acting opioids are .

Oct 8, 2010 . The smoking-cessation aid Chantix is an example of a drug subject to a postapproval risk evaluation and mitigation strategy (REMS).

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