European Clinical Trial Regulations Undergo a Slow Revolution
Implementation of the EU Directive proves to be challenging as regulatory variations among member states continue and questions remain unanswered.
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
Related Content
Juby Mathew;Leslie P. Silva;Chad Bastian;Christopher Williams;Alyssa McBurney;Mark J. Perkins;Vaughan S. Langford
November 11th 2024Article
Pharmaceutical excipients, such as polyethylene glycol-based polymers, must be tested for the presence of ethylene oxide (EtO) and 1,4-dioxane as part of a safety assessment, according to USP Chapter <228>.
AOAC International Awarded NIST Grant for Developing Drug Testing Standards
October 31st 2024Article
The grant will be part of a new collaborative scientific initiative to address the need for standards that define the desired performance of lateral flow immunoassay test strips to detect illicit drugs in tablets and powders.
