Are the risk mitigation measures within a REMS (Risk Evaluation and Mitigation Strategy) adequate enough to ensure optimal benefit-risk management? Even if the FDA doesn’t require a REMS for a product, does it make sense to undertake risk management measures anyway? (more…)
Posts Tagged ‘FDA Guidance’
Complimentary Webinar to Address: Is a ‘Voluntary REMS’ a Good Risk?
Monday, April 11th, 2011ParagonRx Webinar to Provide Guidance On FDA Draft Guidance for MedGuides in REMS
Friday, March 4th, 2011A complimentary webinar will be presented by ParagonRx on the implications and ramifications of the newly released FDA draft guidance, Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).
“Our ‘Guidance’ on the FDA Draft Guidance for MedGuides in REMS” will be the focus of a free webinar which will take place Wednesday, March 9, at 12 noon Eastern Time. The topic is the latest in a series of monthly “Wednesday FoREMS” webinars sponsored by ParagonRx, an inVentiv Health company, pioneering expertise in REMS and Benefit-Risk Management. (more…)
REMS 2010: A Year in Review
Friday, December 3rd, 2010As the pharmaceutical community looks forward to the issuance of the new FDA Risk Evaluation & Mitigation Strategies (REMS) guidance in 2011, a free webinar will examine all the REMS occurrences during the past year and what they will portend for the future. (more…)
Hot Topics in Assessing REMS Examined In ParagonRx October Wednesday FoREMS Webinar
Monday, October 11th, 2010Of the 146 FDA REMS programs approved to date, 41 of them – almost one-third – have already been modified. Undoubtedly, REMS assessment findings have played a role. In addition, new insights arising from FDA comments influence the design of future assessments. These topics will be the focus of a free webinar hosted by ParagonRx which will take place this Wednesday, October 13, at 12 noon Eastern Time. (more…)
REMS Assessments: Insights and Strategies for a Successful Survey Program
Wednesday, May 12th, 2010REMS Assessments are now the hot topic in REMS. We’ve reached the 18-month mark and it’s not a coincidence that Draft Guidance includes a section on assessments and modifications. Companies need to begin to contemplate not just how to analyze and interpret their assessment findings, but they need to think about the best way to actually evaluate their REMS performance. (more…)
Organizing for REMS Effectiveness: A View from the Field
Tuesday, March 30th, 2010- Guest blog by Andrea J. Simon, PhD -
This blog by Andrea Simon, PhD, a corporate anthropologist, is one in a series that ParagonRx has initiated to help our readers better understand some of the trends taking place in the field of Risk Evaluation and Mitigation Strategies (REMS) and risk management under the FDA draft guidance. We know you will find them of value and encourage you to comment on them.
In April, ParagonRx is hosting its Wednesday FoREMS webinar on the topic of organizing to effectively manage Risk Evaluation and Mitigation Strategies (REMS). And, in May, the Wednesday FoREMS will host a panel of industry leaders discussing how their organizations are building REMS capabilities and resourcing them in their product development and commercialization functions. In preparation for these upcoming webinars, I thought I would share with you some of my observations from the field and encourage you to share your own company’s perspectives on how you are reorganizing to create and effectively manage REMS. (more…)
The REMS Sensitivity Index
Tuesday, March 23rd, 2010Below is a qualitative index of the likelihood that FDA may require a REMS for a specific development compound as part of the NDA submission.
The presence of any attribute increases the probability of a REMS requirement; some items may be more highly weighted than others: (more…)
FDLI Conference on REMS: Benefits and Risks Meet Liabilities and Opportunities
Wednesday, February 24th, 2010- Guest blog by Roger Morris, The LondonBritian Company -
You’ve heard all the analogies: Is the glass half empty or half full? Does the dark storm cloud have a silver lining?
I was constantly reminded of this during the Food & Drug Law Institute’s latest conference on REMS held February 16 in Washington, D.C., as the residents and transportation system was trying to dig out of one-two snowstorms. It was an interesting conference, one that built substantially on the groundwork done at last year’s REMS conference which the FDLI co-hosted with ParagonRx. (more…)
VIOXX – What Could Have Been in the Age of REMS
Monday, February 15th, 2010- Guest blog by Wendy Kaplan Nickel -
Perhaps one of the greatest downfalls in drug history was the steep tumble of VIOXX after it was voluntarily pulled from the market in 2004. VIOXX was approved by the FDA in 1999 and quickly became “the” drug for arthritis. It gained widespread acceptance among physicians and over 20 million people were prescribed VIOXX at some point in its 5-year tenure. In fact, in the year prior to VIOXX’s withdrawal from the market, its manufacturer, Merck, experienced sales revenue of $2.5 billion from VIOXX alone. It is assumed Merck certainly had no intention of harming patients with its product, and in fact, celebrated in the fact that so many patients benefitted from the medication. However, it is worth exploring what might have happened if VIOXX’s safety issues had been discovered during the post-FDAAA era.
Are You Attending the FDLI’s Important REMS Conference in Washington?
Friday, February 5th, 2010- Guest blog by Roger Morris, The LondonBritain Company -
Having worked in communications in the pharmaceutical industry for more than 25 years, I continue to be amazed at how even strong competitors remain so open to sharing information and experiences. Perhaps it’s the academic nature of pharmaceutical research that filters out to everyone else in the business, but the industry is constantly talking within itself – from scientific publications about new compounds to physician disease-state annual meetings to specialty conferences.
