Usha Katragadda, Ph.D.

Senior Staff Fellow
US Food and Drug Administration

Poster(s):

• (T0930-10-56) Current Drug Substance Stability Issues Related to the Biopharmaceutics Classification System (BCS) Class III -Based Biowaivers in Abbreviated New Drug Applications (ANDAs)
  Tuesday, October 22, 2024

  9:30 AM – 10:30 AM MT

• (M1030-06-34) In Vitro Permeation Test Outlier Data Evaluation during Bioequivalence Assessment of Abbreviated New Drug Applications
  Monday, October 21, 2024

  10:30 AM – 11:30 AM MT