|Articles|July 1, 2006

LCGC Supplements

  • Special Issues-07-01-2006
  • Volume 0
  • Issue 0

Moving Biotech Products from CBER to CDER: A Work in Progress

A slow, steady process of transitioning biologicals has allayed industry concerns.
External Link - article-416324.pdf

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Analytical Instrument Qualification

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GMP and Phase I Clinical Trials: Streamlining the Critical Path?

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Team Effort

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Rated PG: Pharmaceutical Guidance Suggested

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European Clinical Trial Regulations Undergo a Slow Revolution

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A Practical and Cost-Effective Risk Assessment for the Validation of Commercial Laboratory Computerized Systems

over 19 years ago

FDA Video Interview Conducted by Jill Wechsler, Washington Bureau Chief

over 19 years ago

New Climate

over 19 years ago

2006: A Regulatory Odyssey

over 19 years ago

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

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