How Do You Prove Prejudice in a Protest?
Client Alert | less than 1 min read | 09.26.11
In East West, Inc. v. U.S. (CFC Sept. 21, 2011), Judge Wolski joins a growing number of CFC judges who are more open to receiving affidavits from company officials explaining how the agency's alleged illegality affected the company. While refusing to accept a protestor's affidavit as part of the "administrative record" to explain what the agency did, he allowed it as part of the "court" record to allow the company to meet its burden to show prejudice.
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On December 17, 2025, the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) on a proposal designed to help the FDA engage more directly with innovative, venture-backed companies focused on biotechnology, medical devices, AI, and regulatory technology.[i]The RFI includes 19 questions, with responses due by 2:00 p.m. ET on January 18, 2026.
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