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Date of this Version

9-26-2019

Document Type

Book Chapters

Summary

  • The Food and Drug Administration (FDA)’s primary objective is to ensure safety. Investi­gational New Drugs (INDs) are focused mainly on safety, and therefore, if applicable, preclinical toxicology, manufacturing, and pharmacology data are very important.

  • Take advantage of the FDA’s accelerated programs, where applicable, to expedite commercialization.

  • Engage with the FDA early on to guide your development program and develop relation­ships with the FDA.

  • Consider global opportunities and plan ahead to meet relevant health authority regulations.

  • Academic institutions can offer guidance and regulatory support to faculty investigators.

Creative Commons License

Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

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