Posts Tagged ‘REMS design’
Friday, March 4th, 2011
A complimentary webinar will be presented by ParagonRx on the implications and ramifications of the newly released FDA draft guidance, Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).
“Our ‘Guidance’ on the FDA Draft Guidance for MedGuides in REMS” will be the focus of a free webinar which will take place Wednesday, March 9, at 12 noon Eastern Time.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…)
Tags: benefit-risk, FDA Guidance, FDAAA, medication guide, ParagonRx, REMS, REMS design, Risk Evaluation and Mitigation Strategy, risk management
Posted in FDA Guidance, REMS, Tweets, Webinar | No Comments »
Wednesday, April 7th, 2010
In 2001, ParagonRx first employed the science-based risk assessment methodology Failure Mode and Effect Analysis (FMEA) to proactively assess patient safety in the emerging field of Pharmaceutical Risk Management. While a novel approach for assessing drug safety issues, FMEA has a long history in other risk intensive industries used to mitigate process and design failures, including the aerospace, military, nuclear, and even pharmaceutical manufacturing. Research into how FMEA was used to mitigate risks across other industries and references made in FDA Draft RiskMAP Guidance, provided the rational for applying FMEA to pharmaceutical product and patient safety. RxFMEA®, ParagonRx’s proprietary adaption of the FMEA process, applies the principles of process mapping complex systems and systematically evaluating a process for potential failures. RxFMEA® is a proactive, bottom-up assessment that identifies the behavioral causes of medication use failures and prioritizes interventional opportunities to mitigate adverse events. RxFMEA® was specifically designed as a Pharmaceutical Risk Management tool and is now utilized in REMS development for the pharmaceutical and biotech industries. (more…)
Tags: appropriate use, approval, drug safety, evidence-based, FDA, FMEA, medication use, pharmaceutical safety, REMS, REMS approval, REMS design, REMS program, risk assessment, risk evaluation, RxFMEA, safety issues
Posted in Appropriate Use, General, REMS | No Comments »
Friday, January 8th, 2010
Since 2003, ParagonRx has helped design, document, or negotiate dozens of risk management programs and REMS for pharmaceutical products. Clients who choose to work with us have done so because of three operating principles:
- We believe in a balanced approach to REMS design in which safety objectives are achieved while preserving commercial viability.
- We employ science-based methods to reliably design and measure rational, defendable programs.
- We strive to inspire confidence in clients facing uncertain situations by providing specialized thinking, expert analysis and remarkable responsiveness by our experienced staff.
Those potential clients who did not choose to work with us often cited the need for a firm with broader capabilities to implement communication plans and elements to assure safe use.
At the start of this year, ParagonRx fulfilled its vision of being able to provide end-to-end REMS and risk management services by joining inVentiv Health. (more…)
Tags: communication plan, EASU, Elements to Assure Safe Use, NDA, ParagonRx, REMS, REMS design, risk management, safety
Posted in REMS | No Comments »
Tuesday, December 22nd, 2009
As we advise clients about REMS design and implementation, the most frequent concern we encounter is related to REMS assessment. A look at the math reveals why this is so. Over 63 REMS have been approved since FDAAA statutes for REMS became effective in March 2008. Of those, more than 90% are comprised of Medication Guides and/or Communication Plans, plus an assessment. (more…)
Tags: communication plan, draft guidance, FDA Guidance, FDAAA, guidance, medication, medication guide, ParagonRx, Proposed REMS, REMS, REMS assessment, REMS design, risk evaluation, risk management
Posted in REMS | No Comments »
Thursday, October 15th, 2009
On September 30th, FDA issued draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications”. While much of this draft guidance is a codification of what’s already been happening in practice over the past 2 years, there are some interesting aspects in the guidance for those working in the REMS space to contemplate. This is the fifth in an ongoing series of blog articles about this important document.
Our first four articles covered the background of FDAAA and REMS, an overview of a REMS submission and greater detail about the “Proposed REMS” and “REMS Supporting Document”, and REMS submissions and communications with FDA.
In this fifth and final article, we address our preliminary interpretation of the draft guidance, as well as opportunities for industry to respond and propose further improvements. (more…)
Tags: approval, benefit-risk, EASU, Elements to Assure Safe Use, evidence-based, FDA Guidance, FDAAA, guidance, medication, medication guide, NDA, Proposed REMS, REMS, REMS assessment, REMS design, REMS development, REMS effectiveness, REMS elements, REMS guidance, REMS program, REMS supporting document, risk assessment, risk evaluation, Risk Evaluation and Mitigation Strategy, risk management, RiskMAP, submission
Posted in FDA Guidance, Pharmaceuticals, REMS | Comments Off
Wednesday, September 2nd, 2009
In a constantly changing regulatory environment, having a well planned contingency strategy is vital for successful Food and Drug Administration (FDA) negotiations. Today, this is more important than ever. The FDA is asking companies to prepare Risk Evaluation and Mitigation Strategies (REMS) to help ensure patient safety, and has issued a documentation template, but has yet to provide further guidance to the industry on how such REMS should be developed. (more…)
Tags: approval, communication plan, contingency plan, EASU, Elements to Assure Safe Use, FDA Guidance, guidance, medication, medication guide, patient safety, regulatory, REMS, REMS design, REMS program, risk evaluation, safety
Posted in Pharmaceuticals, REMS | Comments Off
Thursday, July 30th, 2009
One of the more challenging aspects of the new FDA world of REMS is the tension it can create among various functional groups such as Marketing, Risk Management, Safety and Medical within a Pharma or Biotech company. Rules are unclear. Territories are vaguely defined. New objectives seem similar to the old but may not be in reality. And it involves many players, across most internal disciplines. Maybe it’s time that we all think of this as a cross-disciplinary sport that no one really knows how to play well, yet.
The urgency of the new regulatory environment is simply demanding some quick innovative thinking and action.
Some of our clients and others are addressing this new “X-Disciplinary Sport” to good advantage. There are a number of principles that, if kept at the forefront of thinking, can help you re-organize and align your teams around this new REMS-driven world. (more…)
Tags: approval, FDA Guidance, medication, medications, NDA, patient safety, regulatory, REMS, REMS design, risk management, safety
Posted in Appropriate Use, Pharmaceuticals, REMS | No Comments »
Wednesday, January 28th, 2009
FDA and the industry share thoughts at FDLI risk management conference
Earlier this month, while Washington was bustling with Inaugural preparations, there was an excellent meeting in the capital on pharmaceutical risk management, hosted by the Food and Drug Law Institute (FDLI) at the offices of Morgan, Lewis & Bockius LLP. The impetus of the meeting was to provide a forum for some of the authors of the recently published text, Pharmaceutical Risk Management: Practical Applications (FDLI, 2008) as well as other experts within the industry and within the FDA. Industry veteran Wayne Pines, who edited the book along with me and my colleague at ParagonRx, Gary Slatko, chaired the conference.
I would like to share with you some of the more-intriguing thoughts to come out of the conference, as well as a few news tidbits – but first let me say that if you would like to obtain a complete transcript of the conference or to buy a copy of PRM: Practical Applications, please contact the FDLI website at www.fdli.org.
(more…)
Tags: appropriate use, benefit-risk, FDA Guidance, Gary Slatko, guidance, medical devices, medication, medication guide, medications, ParagonRx, pharmaceutical risk management, REMS, REMS design, REMS guidance, REMS program, risk management, risk mitigation
Posted in REMS | No Comments »
