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FDA Drug Topics: Building Confidence in Generic Narrow Therapeutic Index (NTI) Drugs – September 18, 2018

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!

On Tuesday, September 18, 2018, CDER's Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: FDA Drug Topics: Building Confidence in Generic Narrow Therapeutic Index (NTI) Drugs. This webinar introduced the general characteristics of Narrow Therapeutic Index or NTI drugs and discussed FDA's innovative approach and criteria for generic NTI drug equivalence evaluation. In addition, we discussed results from a bioequivalence study comparing brand and generic tacrolimus (an NTI drug) capsules in stable transplant patients to address patients' and health practitioners' questions regarding substitutability of generic immunosuppressant drugs.

View Presentation: https://collaboration.fda.gov/p85i91xieo1/

Download Presentation Slides: Building Confidence in Generic Narrow Therapeutic Index (NTI) Drugs Slides (PDF - 2.06MB)

Activity Outline and Continuing Education Information: Building Confidence in Generic Narrow Therapeutic Index (NTI) Drugs (PDF - 236KB)


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Page Last Updated: 09/21/2018
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