FDA leaves biosim trial data off product labels in new guidance

Carly Helfand

The FDA is out with new for labeling biosimilar drugs–and it may not make some drugmakers happy. Regulators dismissed pharma's request that the label describe the clinical copycats used for approval purposes.

FiercePharma News

Share This Post

Related Articles

Leave a Reply

© 2017 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS