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 | 04.08.26
Cosmetics Under the Microscope: FDA’s Expanding Regulatory Reach Under MoCRA
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marked the most significant expansion of FDA’s authority over cosmetics in 80 years — and the agency is putting that authority to work. From the launch of a new adverse event reporting tool to forthcoming rules on fragrance allergens and good manufacturing practices (GMP), FDA is reshaping the regulatory landscape for manufacturers, packers, and distributors of cosmetic and personal care products.
Client Alert | 11 min read | 04.08.26
Client Alert | 3 min read | 04.07.26
Answering the Top Seven Questions About Pending Section 301 Deadlines
