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FDA Issues First Orders and More Under the CARES Act: Final Administrative Orders, a Sunscreen Proposed Order and the 3-Year Forecast

FDA Law Blog

Livornese — Many of us have been waiting not-so patiently for FDA to begin implementing the over-the-counter (OTC) monograph reform provisions of the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (see our blog post here ). Sunscreen Orders.

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The Evolution of Walmart & its Quest to Become an E-Commerce (and Fashion) Destination

The Fashion Law

In a statement on September 21, Denise Incandela, Walmart’sSVP Women’s Group, Elevated and Online Brands, said, “Through our ongoing strategy of expanding our assortment for our customers, we’ve shown that we’re serious about establishing Walmart as a fashion destination. e-commerce, said in a blog post.

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USD Law Professor Under Investigation For Column Criticizing Chinese Government

JonathanTurley

The column, written on the site The Right Coast discussed a Wall Street Journal article on China’s lack of real cooperation in the World Health Organization’s investigation into the origins of the coronavirus. It is especially concerning when the disparaging language comes from a member of our community. Here is our reaction.

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Retail Woes: A Running List of Fashion & Retail Bankruptcies

The Fashion Law

“We are optimistic about reorganization as we continue to see increasing business in our stores as COVID restrictions are lifted and in the new fashions that our vendors are providing. The New York-based company revealed that it will close all of its 13 brick-and-mortar stores and will liquidate its assets.

Finance 125
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3 in 1 Guidance Issued by FDA Covering Formal Dispute Resolution, Administrative Hearings and Consolidated Proceedings for OTC Monograph Drugs

FDA Law Blog

Under the OTC Monograph User Fee Program commitment letter , FDA committed to modify existing guidance on formal dispute resolution (FDR) process and to issue guidance on consolidated proceedings for appeals.

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Easy as ABC, XYZ – OTC Monograph Meetings Guidance Not So Different from Existing PDUFA Guidance, But with a Few Twists

FDA Law Blog

FDA has adopted a tiered meeting framework not unlike the Type A, B and C meeting categories established under the Draft Guidance for meetings with sponsors of PDUFA products (the PDUFA Guidance). By Deborah L. The Monograph Meeting Guidance describes Type X, Y and Z meetings essentially as they are set out in the Goals Letter.