Vanda Sues US FDA For Documents Backing Complete Response For Hetlioz Jet Lag Indication

 
• By Brenda Sandburg

FOIA exemption does not apply to medical and statistical reviews of its sNDA, company claims. It says it needs the information to adapt its development program and determine if the agency made an error.

Jet lag
Vanda fights FDA for documents pertaining to jet lag indication for Hetlioz • Source: Alamy

More from Complete Response Letters

More from Product Reviews