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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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.
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EU Pharma Package: Fiscal Imports in the Supply Chain Compromise Proposal
