Biotech Values

[Biowatch]

SPA - From the FDA website:

[This seems a little ambiguous, in that it says you can't submit it after the protocol has started. However, it does imply you can get an SPA after a protocol has started if they let you and you forego the 45 day PDUFA time frame.]

http://www.fda.gov/cber/gdlns/protocol.htm#iii
PROCEDURES FOR REQUESTING SPECIAL PROTOCOL ASSESSMENT

Under the PDUFA goals, FDA will evaluate certain protocols when the sponsor requests evaluation. A separate request should be submitted for each specific protocol the sponsor would like reviewed. The procedures for requesting special protocol assessment are described below.

1. Timing of Request

CDER and CBER generally recommend that a sponsor submit a protocol intended for special protocol assessment to the Agency at least 90 days prior to the anticipated start of the study. The protocol should be complete, and enough time should be allowed to discuss and resolve any issues before the study begins. Special protocol assessment will not be provided after a study has begun.6 Protocols for studies that have already begun can be evaluated by CDER and CBER, but they do not qualify for the 45-day time frame described in the PDUFA goals.

http://www.fda.gov/cber/gdlns/protocol.htm