Posts Tagged ‘regulatory’
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trends taking place in the field of Risk Evaluation and Mitigation Strategies (REMS) and risk management under the FDA draft guidance.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Tags: appropriate use, communication plan, contingency plan, draft guidance, Elements to Assure Safe Use, FDA Guidance, FDAAA, guidance, NDA, ParagonRx, regulatory, REMS, REMS approval, REMS development, REMS effectiveness, REMS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 »
Tuesday, March 23rd, 2010
Below is a qualitative index of the likelihood that FDA may require a REMS for a specific development compound as part of the NDA submission.
The presence of any attribute increases the probability of a REMS requirement; some items may be more highly weighted than others: (more…)
Tags: clinical trials, Drug, drug interactions, FDA Guidance, mechanism of action, NDA, nda submission, ParagonRx, prolongation, regulatory, REMS, REMS development, REMS program, risk assessment, risk evaluation, sensitivity index, serious adverse event, stakeholder, submission, teratogenicity
Posted in 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 Guidance, FDLI, Gary Slatko, ParagonRx, regulatory, REMS, REMS program
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 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
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 | Comments Off
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 | Comments Off
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 Guidance, FMEA, medication, medications, NDA, ParagonRx, regulatory, REMS, REMS effectiveness, risk assessment, risk management, risk mitigation, safety
Posted in Pharmaceuticals, REMS | Comments Off
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 | Comments Off
Thursday, July 30th, 2009
One of the more challenging aspects of the new FDA world of REMS is the tension it can create among various functional groups such as Marketing, Risk Management, Safety and Medical within a Pharma or Biotech company. Rules are unclear. Territories are vaguely defined. New objectives seem similar to the old but may not be in reality. And it involves many players, across most internal disciplines. Maybe it’s time that we all think of this as a cross-disciplinary sport that no one really knows how to play well, yet.
The urgency of the new regulatory environment is simply demanding some quick innovative thinking and action.
Some of our clients and others are addressing this new “X-Disciplinary Sport” to good advantage. There are a number of principles that, if kept at the forefront of thinking, can help you re-organize and align your teams around this new REMS-driven world. (more…)
Tags: approval, FDA Guidance, medication, medications, NDA, patient safety, regulatory, REMS, REMS design, risk management, safety
Posted in Appropriate Use, Pharmaceuticals, REMS | No Comments »
