CDER?s Division of Post-Marketing Evaluation for Quality Assessment
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.
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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