How to Meet Regulatory Challenges in the New Year - Pharmaceutical Technology

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How to Meet Regulatory Challenges in the New Year
With 2007 projects wrapped up, or so we hope, forward-looking companies need to take their next step.

Pharmaceutical Technology
Volume 32, Issue 1

Although a RiskMAP's primary purpose is to communicate actions a company will take to minimize risk, an effective RiskMAP should do so while preserving the plan's benefits.

In March 2005, FDA issued the Guidance for Industry: Development and Use of Risk Minimization Action Plans. This guidance emphasizes the agency's shift in evaluation of products, from a safety and efficacy model, to a benefit versus risk model, ensuring that the benefits outweigh the risks. Some experts have applauded this change, stating that no effective product can be completely safe because potential for adverse reaction among consumers almost always exists —and that, therefore, measuring benefit to risk is more practical and useful. According to the guidance:

Benefit and risk information emerges continually throughout a product's life cycle (i.e., during the investigational and marketing phases) and can reflect the results of both labeled and off-label uses. Benefits and risks can result in a range of corresponding positive and negative effects on patient outcomes that may: (1) Be cosmetic, symptomatic, or curative; (2) Alter the course of the disease ; and (3) Affect mortality. Benefits and risks are difficult to quantify and compare because they may apply to different individuals and are usually measured and valued differently. (1)


The year 2008 will be challenging for pharmaceutical companies given the ever evolving requirements of the FDA. Although this fact should not come as a surprise to anyone in the industry, companies still need to be prepared and be able to move quickly so as not to compromise their businesses.

Patricia Santos-Serrão, RAC, is a regulatory advisor in the life-sciences practice at QUMAS,


1. FDA, Guidance for Industry: Development and Use of Risk Minimization Action Plans (Rockville, MD, March 2005).


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