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Re: foxhound02 post# 65685

Tuesday, 06/28/2016 12:45:57 AM

Tuesday, June 28, 2016 12:45:57 AM

Post# of 690696
WRONG! Do a simple search on BLA filings or other "typical FDA public required announcements" and you will see that ALL disclosures are subject to FOIA.

After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown:

If filings/records contain trade secrets and confidential commercial information then such information may not be made public and are subject to Freedom of Information Act, the Trade Secrets Act, the Privacy Act.

https://www.law.cornell.edu/cfr/text/21/601.51

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125650.pdf

Section II Background
A.
Relevant Statutes and Regulations

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