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.
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.
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.
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.
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.