Group Letter to FDA on Tiamulin Drug Safety Data

The type 2 supplemental approval of tiamulin is the third of its kind since retapamulin was approved for humans in 2007. Each of these approvals was an opportunity for FDA to require drug sponsors to provide microbial safety data related to antimicrobial resistance. Yet in each case the Agency failed to act.

Comment to FDA on Draft Guidance #209, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals

This joint letter, submitted by Keep Antibiotics Working to the FDA, Docket No. FDA-2010-D-0094, addresses the issue of the FDA not doing enough about the overuse of antibiotics in food animals.