Friday, January 9, 2009

21Part CFR FDA Guidelines "are" Critical Path Tools

From the Desk of Dante.

How important are "Critical Path Tools", commonly know as FDA Guidelines? Extremely important. Yes, you are correct, guidelines are not "requirements", however, in many cases, will have greater impact on the overall success of the drug's development phase and ultimate chance for approval.

FDA Critical Path Tools {Guidelines}:
  • are science-based documents that eliminate uncertainly and ensure quality and integrity
  • will provide valid evidence of product safety and efficacy
  • will provide manufacturing quality and consistency.

I encourage all stakeholders to:

  • collaborate
  • improve
  • negotiate
  • and communicate...with FDA on guidelines, and of course, follow the requirements.

Start today!

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