Seismic Policy Shift to Open VA Schedule Contract to Non-TAA Compliant Covered Drugs
Client Alert | less than 1 min read | 04.21.16
On April 19, 2016, VA posted new guidance mandating that all manufacturers of covered drugs offer to the VA all such drugs, regardless of country of origin, so that VA may evaluate for non-availability waivers. While this major shift in policy potentially reopens sales of non-TAA compliant covered drugs to VA hospitals and other purchasers under a 65 I B VA Federal Supply Schedule contract, the fast approaching and tight deadlines require (a) existing FSS contract holders quickly to calculate and modify their contract to include pricing information about such covered drugs and (b) those manufacturers without an FSS contract quickly to initiate obtaining one.
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Client Alert | 4 min read | 01.07.26
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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New Year, Same CIPA Uncertainty – When Will the Appellate Courts Enter the Chat?
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