Posts Tagged ‘REMS elements’
Wednesday, May 26th, 2010
Sponsors are struggling with how to adapt research survey methods to meet the regulatory reporting standards of REMS assessments. Assessments need to be designed in a way that measure risk mitigation. Reports and interpretation of findings are highly qualitative and declarations of success may be inconsistent with those findings.
REMS assessments should be designed in a meaningful manner for measuring specific objectives. It’s important to start with a rational design – balance the interests of regulators, customers, and manufacturers. The design should be evidence-based and include end users in the design process. (more…)
Tags: FDA draft guidance, ParagonRx, patient safety, REMS, REMS assessment, REMS elements, Risk Evaluation and Mitigation Strategy
Posted in Appropriate Use, 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 We’ve reached the 18-month mark and it’s not a coincidence that Draft Guidance includes a section on assessments and modifications.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 »
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On September 30th, FDA issued draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications”. While much of this draft guidance is a codification of what’s already been happening in practice over the past 2 years, there are some interesting aspects in the guidance for those working in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In this fifth and final article, we address our preliminary interpretation of the draft guidance, as well as opportunities for industry to respond and propose further improvements.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
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 | Comments Off
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 | Comments Off
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 | Comments Off
Wednesday, August 12th, 2009
Your company wouldn’t launch a new product and wait for the end-of-year results before assessing whether the launch strategy was effective, correct? In fact, the process most pharmaceutical product managers employ includes weekly measurement of prescription volume, tracking product inventory, assessing distribution patterns of promotional materials, measuring knowledge/attitude/practices of prescribers, and adjusting marketing activities to achieve success.
So why would tracking and adjusting risk management activities be any different? FDA requires an assessment of REMS performance at intervals no less frequently than 18 months, 3 years, and 7 years post launch. What are you doing before and between formal assessments to actively manage and maximize the effectiveness of the REMS? (more…)
Tags: benefit-risk, EASU, FDA Guidance, patient safety, REMS, REMS document, REMS effectiveness, REMS elements, REMS program, risk management, safety
Posted in Pharmaceuticals, REMS | No Comments »
Monday, July 20th, 2009
Today we want to focus on key lessons learned from our clients’ experiences. We are very grateful to these clients for allowing us to share their experiences with you so that you can do a better job in your REMS process.
Let’s begin with something that happened recently as we were working with a client during the tight 90-day period before they presented their PDUFA.
Expect the Unexpected
As we work with our clients on their REMS process, we are learning a lot about the uncertainties of interfacing with an internal FDA process that is itself a work in process. One thing that has become very apparent is that no matter how much advanced preparation you believe you have done, the FDA might just surprise you. (more…)
Tags: approval, contingency plan, FDA Guidance, PDUFA, REMS, REMS document, REMS elements, REMS program
Posted in 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 »
