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FDA Inspections Are Changes On The Horizon

FDA Inspections: Are Changes On The Horizon? By Kalah Auchincloss, SVP & deputy general counsel, Greenleaf Health, Inc. Almost exactly one year ago, in March 2020, the U.S. FDA announced that it was suspending all foreign and domestic inspections except those it deemed “mission critical.”[1] This unusual move was a response to the then-emerging COVID-19 pandemic an attempt to reduce transmission of the virus and protect both FDA personnel and industry employees. Even as it suspended inspections, the agency assured the public that it had “full confidence in the safety and quality of the products we all use every day and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate.”[2] A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply.

Pittsburgh s Pirates Possibly Peeved after CBP Seizes Shipments of Eye Patches

Pittsburgh’s Pirates Possibly Peeved after CBP Seizes Shipments of Eye Patches Details Written by IVN Pittsburgh, Pennsylvania - There are likely to be some perturbed plundering pirates pillaging around Pittsburgh, but U.S. Customs and Border Protection (CBP) only wants to ensure that they sack the city safely. CBP officers seized medicated eye patches in Pittsburgh that were unapproved for use in the U.S. That’s because CBP officers seized 3,740 potentially harmful medicated eye patches on Saturday that the U.S. Food and Drug Administration determined to be unapproved for sale in the United States. The patches initially arrived in two shipments from Hong Kong. The first shipment arrived on January 4 and consisted of 2,300 medicated eye patches. The second shipment of 1,440 medicated eye patches arrived on February 8. Both shipments were destined to separate addresses in Allegheny County, Pa. Upon close examination, none of the packaging contai

Form 10-K IDEAYA Biosciences, Inc For: Dec 31

Form 10-K IDEAYA Biosciences, Inc For: Dec 31
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Structure/Function Claims Are Preempted, Ninth Circuit Says

Tuesday, February 2, 2021 Last month, the United States Court of Appeals for the 9 th Circuit affirmed a grant of summary judgment in favor Target and other defendants in a class action lawsuit that alleged that Target’s Up&Up biotin dietary supplement violated various California consumer protection statutes because it claimed to  “help[ ] support healthy hair and skin.” Specifically, the Court held that (1) the statement was a “structure/function” claim governed by the Federal Food Drug and Cosmetic Act (the “Act”), (2) Plaintiff sought to impose different requirements from the Act, and (3) therefore, the claim was preempted. By way of background, a “structure/function” claim is one that describes the function or role of an ingredient or nutrient in the human body. 

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