Incorporating Alternative Approaches in in Clinical Investigations for New Animal Drugs

The ANIMAL HEALTH INSTITUTE (AHI) submits these comments to Docket No. FDA-2019-N-2281 Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs. We respectfully submit the following comments for your consideration. These written comments are intended to complement verbal comments provided during the July 16th public meeting. Comments are provided for each of the topics.

The Animal Health Institute (AHI) respectfully submits the following transcripts to the record. These transcripts reflect public comments delivered on July 16, 2019.