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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Client Alert | 5 min read | 04.13.26
EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal
In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product.
Client Alert | 4 min read | 04.13.26
Client Alert | 4 min read | 04.10.26
CMS Finalizes Rate Notice for Medicare Parts C and D (CY 2027)
Client Alert | 2 min read | 04.10.26
