|Articles|July 1, 2006

LCGC Supplements

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

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.
External Link - article-416316.pdf

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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

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

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FDA Video Interview Conducted by Jill Wechsler, Washington Bureau Chief

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New Climate

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2006: A Regulatory Odyssey

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