Documents & Links
FEMA Resources
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2015 FEMA Comments to FDA on the “Utility and Usability” of the IID
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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)