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Documents & Links

FEMA Resources

  • 2015 FEMA Comments to FDA on the “Utility and Usability” of the IID

  • A CDER Pharmacology Toxicology Perspective on the Safety Evaluation of Flavor Excipients

  • Introduction to Flavors in Pharmaceutical Products Presentation

External Resources

  • FDA’s Inactive Ingredient Database
  • FDA Good ANDA Submission Practices Guidance for Industry (January 2022)
  • FDA OPQ MAPP: Evaluating Color Additives and Flavors Intended for Oral Drug Products Submitted or Referenced in INDs and NDAs (June 2021)
  • FDA Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients Guidance (May 2005)

 

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