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FTC Crackdown on False or Misleading “Made in the USA” Claims

The US Federal Trade Commission (FTC) is intensifying a crackdown on goods that are falsely or misleadingly marketed as “made in the USA.” Since the FTC, in its Made in USA Labeling Rule, 86 FR 27022 (July 14, 2021), 16 C.F.R...more

DOJ Seeks 10-Year Prison Sentences in First Consumer Product Safety Conviction

This month, the government is asking for a pair of 10-year prison sentences for two Gree USA Inc. executives convicted of failing to report defective humidifiers. This comes after the two were found guilty of conspiracy to...more

Commercial Leasing in Massachusetts: Contractual Limitation of Liability Provisions Unenforceable for Willful or Knowing...

The Massachusetts Supreme Judicial Court on January 24 issued an important decision impacting commercial landlords’ potential exposure to liability for multiple damages under Chapter 93A in H1 Lincoln, Inc. vs. South...more

U.S. Supreme Court Rules Against Ford in Personal Jurisdiction Battle

The U.S. Supreme Court issued an important decision impacting personal jurisdiction Thursday in Ford Motor Co. v. Montana Eighth Judicial District Court et. al. and Ford Motor Co. v. Adam Bandemer, a pair of cases about...more

Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars

On December 27, 2020, the President signed into law the “Consolidated Appropriations Act, 2021” (the “Act”). Included within this omnibus legislation are several provisions (in Division BB, Title III, Subtitle C) that affect...more

COVID-19 Liability Shields for Nursing Homes and Long-Term Care Facilities in the U.S.

As of July 30, 2020, at least 62,000 residents and employees of nursing homes and long-term care facilities have died in the United States as a result of the COVID-19 pandemic and over 300,000 more have been infected with the...more

Qualifying for Immunity Under the U.S. PREP Act During COVID-19

As part of the U.S. government’s response to the COVID-19 pandemic, on March 10, 2020, the Secretary of Health and Human Services (“Secretary”) issued a Declaration pursuant to the Public Readiness and Emergency Preparedness...more

FDA Draft Guidance on Updating Generic Labels When RLD Withdrawn

On Friday, the FDA issued a draft guidance document intended to provide ANDA holders with information about how and when to propose any necessary labeling updates to their drugs when the reference-listed drug (RLD) upon which...more

FDA Holds Public Hearing On Proposed Label Change Rule

On March 27, 2015, the FDA held a public meeting regarding its proposed generic drug labeling rule, a rule that would allow ANDA holders to unilaterally update labeling prior to FDA approval. Testimony from proponents of the...more

FDA Revisits Its Proposed Rule Regarding Generic Drug Labeling

On February 18, 2015, the FDA announced that it is reopening the comment period for its proposed rule that would allow ANDA holders to unilaterally update their generic drug product labels prior to the NDA holder doing so....more

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