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 | 7 min read | 12.17.25
After hosting a series of workshops and issuing multiple rounds of materials, including enforcement notices, checklists, templates, and other guidance, the California Air Resources Board (CARB) has proposed regulations to implement the Climate Corporate Data Accountability Act (SB 253) and the Climate-Related Financial Risk Act (SB 261) (both as amended by SB 219), which require large U.S.-based businesses operating in California to disclose greenhouse gas (GHG) emissions and climate-related risks. CARB also published a Notice of Public Hearing and an Initial Statement of Reasons along with the proposed regulations. While CARB’s final rules were statutorily required to be promulgated by July 1, 2025, these are still just proposals. CARB’s proposed rules largely track earlier guidance regarding how CARB intends to define compliance obligations, exemptions, and key deadlines, and establish fee programs to fund regulatory operations.
Client Alert | 1 min read | 12.17.25
Client Alert | 7 min read | 12.17.25
Executive Order Tries to Thwart “Onerous” AI State Regulation, Calls for National Framework
Client Alert | 4 min read | 12.17.25
The new EU Bioeconomy Strategy: a regulatory framework in transition
