Posts Tagged ‘benefit-risk’
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On September 30th, FDA issued draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications”. While much of this draft guidance is a codification of what’s already been happening in practice over the past 2 years, there are some interesting aspects in the guidance for those working in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In this fifth and final article, we address our preliminary interpretation of the draft guidance, as well as opportunities for industry to respond and propose further improvements.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 »
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 »
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 »
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 »
