Posts Tagged ‘FDAAA’
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trends taking place in the field of Risk Evaluation and Mitigation Strategies (REMS) and risk management under the FDA draft guidance.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Tags: appropriate use, communication plan, contingency plan, draft guidance, Elements to Assure Safe Use, FDA Guidance, FDAAA, guidance, NDA, ParagonRx, regulatory, REMS, REMS approval, REMS development, REMS effectiveness, REMS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 »
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 | No Comments »
Tuesday, October 13th, 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 a few interesting surprises (depicted in bold below) for those working in the REMS space to contemplate. This is the fourth in an ongoing series of blog articles about this important document.
Our first three 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” components of the REMS document submission. This article covers the section of the guidance about “REMS assessment and modification submissions” and “communicating with FDA”. (more…)
Tags: approval, approved REMS, biologics, FDA Guidance, FDAAA, generic drug, guidance, Proposed REMS, regulatory, REMS, REMS assessment, REMS document, REMS elements, REMS guidance, REMS supporting document, risk evaluation, Risk Evaluation and Mitigation Strategy, submission
Posted in FDA Guidance, Pharmaceuticals, REMS | No Comments »
Wednesday, October 7th, 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 2 years, there are a few interesting surprises (depicted in bold below) for those working in the REMS space to contemplate. This is the third in an ongoing series of blog articles about this important document.
Our first two articles covered the background of FDAAA and REMS relative to RiskMAPs and those RiskMAPs deemed to be REMS, an overview of a REMS submission, and greater detail about the more concise “proposed REMS” component of the REMS document submission. This article details the content of the more comprehensive “REMS Supporting Document”, which explains the rationale for, and supporting information about, the proposed REMS. A template for the REMS Supporting Document can be found on the www.fda.gov website. (more…)
Tags: approval, EASU, Elements to Assure Safe Use, FDA Guidance, FDAAA, guidance, medication, medication guide, Proposed REMS, regulatory, REMS, REMS approval, REMS assessment, REMS document, REMS elements, REMS supporting document, risk evaluation, Risk Evaluation and Mitigation Strategy, risk management, RiskMAP, safety, submission
Posted in FDA Guidance, Pharmaceuticals, 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, April 8th, 2009
What a difference a year makes…
In early 2008, the topic of risk management was greeted with aversion by most pharmaceutical managers responsible for commercial activities. “If I encounter a drug with genuine safety concerns, I’ll call you” was a frequent response.
Today, everyone is talking about risk management… and for good reason. The FDA Amendment Act (FDAAA) of 2007 granted FDA sweeping new authority to require Risk Evaluation and Mitigation Strategies (REMS) of any product at any stage of lifecycle. In response to FDAAA, industry had three immediate questions:
- What determines if REMS will be necessary?
- How actively will FDA implement the REMS provisions?
- Who should be thinking about risk management?
(more…)
Tags: benefit-risk, contingency plan, evidence-based, FDA Guidance, FDAAA, FMEA, medication, ParagonRx, patient safety, pharmaceutical safety, REMS, REMS elements, REMS program, risk assessment, risk evaluation, risk management, safety
Posted in Pharmaceuticals, REMS | No Comments »
