Posts Tagged ‘communication plan’
Monday, July 12th, 2010
-Guest Blog by Andrea J. Simon, PhD.-
In the past year, pressures to integrate observational or ethnographic research (which really are one and the same) in pharmaceutical and biotech industries are increasing as the value of this research is becoming better understood. In particular, Phase IV research involving the management and use of a drug protocol is becoming more and more important; i.e., when a drug is in widespread use, risks need to be better understood. At the same time, there is a growing sense of uncertainty around ethnography’s legitimate role, how to integrate it into quantitative research, and when to use its information and insights to support or alter a previously defined direction. Along with this greater scrutiny, there is rising debate about ‘best practices’ in observational research processes, especially regarding the need to define protocols to ensure that research is conducted with proper rigor and is producing suitable, credible results. (more…)
Tags: appropriate use, approval, clinical trials, communication plan, Drug, ethnography, medication, medication guide, observational, ParagonRx, patient safety, REMS, REMS implementation, research
Posted in REMS | No Comments »
Wednesday, May 12th, 2010
REMS 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 We’ve reached the 18-month mark and it’s not a coincidence that Draft Guidance includes a section on assessments and modifications.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…)
Tags: communication plan, Elements to Assure Safe Use, FDA Guidance, guidance, REMS, REMS assessment, REMS effectiveness, REMS elements, REMS guidance, risk assessment
Posted in Appropriate Use, FDA Guidance, REMS | No Comments »
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trends taking place in the field of Risk Evaluation and Mitigation Strategies (REMS) and risk management under the FDA draft guidance.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…)
Tags: appropriate use, communication plan, contingency plan, draft guidance, Elements to Assure Safe Use, FDA Guidance, FDAAA, guidance, NDA, ParagonRx, regulatory, REMS, REMS approval, REMS development, REMS effectiveness, REMS implementation, REMS program, risk evaluation, Risk Evaluation and Mitigation Strategy, risk management, risk mitigation
Posted in General, REMS | No Comments »
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.
(more…)
Tags: cardiovascular risk, communication plan, EASU, FDA Guidance, FDAAA, heart attack, medication, medication guide, merck, NDA, REMS, risk management, safety, safety issues, vioxx, wendy kaplan nickel
Posted in REMS | 2 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 »
Monday, October 5th, 2009
On September 30th, FDA issued its long awaited 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 two years, there are a few interesting surprises (depicted in bold below) for those working in the REMS space to contemplate. This is the second in an ongoing series of blog articles about this important document.
Our first article covered the background of FDAAA and REMS relative to RiskMAPs and those RiskMAPs deemed to be REMS, as well as an overview of a REMS submission. This second article addresses, in greater detail, the more concise “proposed REMS” component of the REMS document submission. The more expanded “REMS supporting document”, explaining the rationale for, and supporting information about, the proposed REMS being addressed in the next article. (more…)
Tags: communication plan, EASU, Elements to Assure Safe Use, FDA Guidance, FDAAA, guidance, medication, medication guide, NDA, Proposed REMS, REMS, REMS assessment, REMS document, REMS elements, REMS supporting document, risk evaluation, Risk Evaluation and Mitigation Strategy, RiskMAP, safety, submission
Posted in FDA Guidance, Pharmaceuticals, REMS | No Comments »
Wednesday, September 30th, 2009
FDA issued its long awaited draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications”, on September 30. While much of the guidance is codification of what’s already been happening in practice over the past two years, there are a few surprises (indicated here in bold) for all of us working in the REMS space to contemplate. This is the first in a series of blog posts about this important document. (more…)
Tags: approved REMS, communication plan, deemed REMS, EASU, Elements to Assure Safe Use, FDA Guidance, FDAAA, guidance, medication, medication guide, NDA, Proposed REMS, regulatory, REMS, REMS assessment, REMS document, REMS guidance, REMS supporting document, risk evaluation, Risk Evaluation and Mitigation Strategy, risk management, RiskMAP, safety, submission
Posted in FDA Guidance, Pharmaceuticals, REMS | No Comments »
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 | No Comments »
