Avid Bioservices Inc (CDMO)

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HHS Pandemic Influenza Plan

http://www.hhs.gov/pandemicflu/plan/

7: Antiviral Drug Distribution and Use
i) Contingency planning for Investigational New Drug (IND) use.

State and local health departments should be prepared to distribute unlicensed antiviral drugs (if needed) under FDA’s
Investigational New Drug (IND) provisions. IND provisions require strict inventory control and recordkeeping, completion of a
signed consent form from each person who receives the medication, and mandatory reporting of specified types of adverse
events. IND provisions also require approval of the protocol and consent form by an Institutional Review Board (IRB). The FDA
regulations permit the use of a national or "central" IRB. A treatment IND is one IND mechanism that FDA has available for
use and is especially suited for large scale use of investigational products. http://www.access.gpo.gov/nara/cfr/waisidx_99/
21cfr_99.html
As an alternative to IND use of an unapproved antiviral drug, HHS may utilize the drug product under Emergency Use
Authorization procedures </U>as described in the FDA draft Guidance "Emergency Use Authorization of Medical Products"
http://www.fda.gov/cber/gdlns/emeruse.pdf