Biotech Values

[flatlander_60048]

Would expedited discovery apply just to Amphastar-Watson records or might MNTA subpena FDA to be allowed to view their files. While this could be very interesting (in a perfect world), I'm certain both FDA and Amphastar would have the opportunity to remove or redact files due to trade secret and/or Agency confidentiality.

Based on my quick perusal of the attached file it looks like the files could be subpenaed from FDA but I don't think the process could be completed under the guise of expedited discovery.

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm073572.pdf

Regards
FL