Special Issues-07-01-2006

In the most general sense, validation refers to a process that consists of at least four distinct components or steps: software, instruments, methods or procedures, and system suitability.

FDA is modernizing and streamlining the regulatory processes for product development. This article examines FDA's proposed rule to exempt the production of Phase 1 clinical trial materials from the GMP regulations and questions whether this proposed exemption will truly improve public health and promote faster and more predictable access to new medicines.

Brice Collaboration is replacing competitive edge when it comes to sales compliance training.

PhRMA and FDA are in agreement that direct-to-consumer advertising needs reform. The question is: What's the best way to get it?

Implementation of the EU Directive proves to be challenging as regulatory variations among member states continue and questions remain unanswered.

The two questions to ask when considering the validation of computerized laboratory systems are "Do I need to validate the system?" and,if so,"How much work do I need to do?" This article provides a simple framework to answer these questions at the system level.

A slow, steady process of transitioning biologicals has allayed industry concerns.

Dr. Steven Galson, CDER Director, on Drug Risks, Regulation and Research

Europe?s new advertising controls and efforts to institute anti-fraud measures are looking more and more like those in the United States.

The regulatory environment is changing and is starting to sweep away some of the commandments on which we have relied, and to change others almost unrecognizably. To make the transition, FDA will have to reinvent itself and industry will have to rethink the way we develop and manage our processes.

The new Division of Post Marketing Evaluation in the Office of New Drug Quality Assessment has implemented an improved system for managing the submission and review processes for post approval chemistry, manufacturing, and controls change supplements.

In the clinical trials arena, integrated software solutions help life science companies meet ever more stringent compliance challenges.

Two experts in the GCP field answer common questions about clinical trials and regulatory compliance.

The world of manufacturing compliance is abuzz, and the rate of regulatory change has been evolving faster recently.

At the same time the pharmaceutical industry faces new and complex issues with the drug development process and clinical trial environment, regulatory policies are increasing and adding to the burden of cost and time to market.

This paper outlines the current situation in manufacturing and quality operations relative to industry compliance initiatives and manufacturing challenges. It profiles an innovative ?method-centric? software platform, designed for the analyst or operator, to electronically execute and man-age quality control testing protocols and production batch records, yielding significant reductions in overall product release cycle time.

The FDA has been implementing several changes in the way it does business, for example, relying on third-party inspections, academia, and industry in many new ways. The implementation of process analytical technology is among these changes.

Validation is one of the most critical issues facing today?s chromatographers and spectroscopists. With developments in this area moving for-ward at a staggering pace, it is more critical than ever that scientists have the most up-to-date information possible on validation.

Pharmaceutical marketing and sales folks are now contending within creased government scrutiny of direct-to-consumer advertising and pharma-doctor relationships.

Safety and ethical concerns generate additional reporting and disclosure policies despite efforts to streamline research requirements.

This article describes the current situation in FDA-regulated areas, as well as characterization of these products. Finally,the author discusses the various stages of early- and late-phase product developments.