2006: A Regulatory Odyssey
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.
Articles in this issue
Analytical Instrument Qualification
GMP and Phase I Clinical Trials: Streamlining the Critical Path?
Team Effort
Rated PG: Pharmaceutical Guidance Suggested
European Clinical Trial Regulations Undergo a Slow Revolution
A Practical and Cost-Effective Risk Assessment for the Validation of Commercial Laboratory Computerized Systems
Moving Biotech Products from CBER to CDER: A Work in Progress
FDA Video Interview Conducted by Jill Wechsler, Washington Bureau Chief
New Climate
2006: A Regulatory Odyssey
CDER?s Division of Post-Marketing Evaluation for Quality Assessment
Better Compliance Through Technology
Good Clinical Practice Q&A
Keeping Pace
The Growing Regulatory Burden and Revolution in Global Clinical Trials
Recent Videos
The Current Challenges Mitigating PFAS
The Role of PFAS Impacting Carbon Fluxes
Understanding the Movement of PFAS in the Environment
Where Will Your Data Take You? How Modern Lab Informatics Unlocks Your Potential
The Interactions Between Bacterial Communities and PFAS
The Challenges of Characterizing PFAS in the Environment
Inside the Laboratory: The Mead Group at UNC Wilmington and the North Carolina PFAS Testing Network
Exploring Molecular Dynamics: An Interview with Ezgi Gürler of FeMS
Developing Advanced Fragmentation Schemes: An Interview with Ezgi Gürler of FeMS
Advancing Science Through Diversity: A Conversation with Women in Chromatography, Part 5
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