Archive for the ‘Pharmaceuticals’ Category
Wednesday, February 24th, 2010
- Guest blog by Roger Morris, The LondonBritian Company -
You’ve heard all the analogies: Is the glass half empty or half full? Does the dark storm cloud have a silver lining?
I was constantly reminded of this during the Food & Drug Law Institute’s latest conference on REMS held February 16 in Washington, D.C., as the residents and transportation system was trying to dig out of one-two snowstorms. It was an interesting conference, one that built substantially on the groundwork done at last year’s REMS conference which the FDLI co-hosted with ParagonRx. (more…)
Tags: approval, Drug, EASU, FDA, FDLI, Gary Slatko, NDA, opioids, ParagonRx, REMS, risk management, Roger Morris
Posted in Pharmaceuticals, REMS | No Comments »
Friday, February 5th, 2010
- Guest blog by Roger Morris, The LondonBritain Company -
Having worked in communications in the pharmaceutical industry for more than 25 years, I continue to be amazed at how even strong competitors remain so open to sharing information and experiences. Perhaps it’s the academic nature of pharmaceutical research that filters out to everyone else in the business, but the industry is constantly talking within itself - from scientific publications about new compounds to physician disease-state annual meetings to specialty conferences.
(more…)
Tags: FDA, FDLI, Gary Slatko, ParagonRx, regulatory, REMS, REMS program
Posted in Pharmaceuticals, 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On September 30th, FDA issued draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications”. While much of this draft guidance is a codification of what’s already been happening in practice over the past 2 years, there are some interesting aspects in the guidance for those working in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In this fifth and final article, we address our preliminary interpretation of the draft guidance, as well as opportunities for industry to respond and propose further improvements.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, 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 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, 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 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, 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 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, 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 Pharmaceuticals, REMS | 1 Comment »
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, 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 Pharmaceuticals, REMS | No Comments »
Thursday, September 24th, 2009
Description of RxFMEA™
RxFMEA™ is a proprietary modification and extension of the basic FMEA methodology and that of Healthcare FMEA (HFMEA™), an adaptation of FMEA that was developed by the U.S. Veteran’s Administration. My review of the process suggests that the objective of RxFMEA™ is the comprehensive management of risks in the pharmaceutical industry. Because of the active involvement of trained personnel and untrained consumers in the distribution and use of pharmaceuticals, RxFMEA™ extends the basic FMEA and HFMEA™ processes in the following ways (more…)
Tags: EASU, FMEA, medication, NDA, ParagonRx, regulatory, REMS, RxFMEA, safety
Posted in Pharmaceuticals, REMS | No Comments »
Thursday, September 3rd, 2009
Airplanes and medications seem like items that don’t mix well. In fact, the discussion of a recent webinar suggests otherwise, at least as it relates to risk management. Captain Ben Berman shared experiences from his role as former Chief of Major Investigations of the U.S. National Transportation Board in which he served as a member of the major accident go-team responsible for safety studies about flight crew human factors. (more…)
Tags: FDA, FMEA, medication, medications, NDA, ParagonRx, regulatory, REMS, REMS effectiveness, risk assessment, risk management, risk mitigation, safety
Posted in 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, medication, medication guide, patient safety, regulatory, REMS, REMS design, REMS program, risk evaluation, safety
Posted in Pharmaceuticals, REMS | No Comments »
