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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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News

At long last, landmark OTC Drug reform legislation is enacted

On March 27, 2020, as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), U.S. President Trump signed into law a long-awaited overhaul of the regulatory system for...

News

First emergency use authorization for COVID-19 drugs may open door for more EUAs

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) allowing distribution of two decades-old malaria drugs — Chloroquine Phosphate and...

News

The global impact of COVID-19 on clinical trials and countermeasure development
Registered Content

The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of...

Insights

“Misleading” to suggest a biosimilar is inferior, FDA draft guidance warns
Registered Content

As part of its continuing efforts to advance biologics competition, the U.S. Food and Drug Administration (FDA) on February 3 published a 10-page Q&A draft guidance, “Promotional...

Insights

2019 OPDP enforcement letters target how drug risk information is conveyed in promotional materials
Registered Content

In 2019, the U.S. Food and Drug Administration's ("FDA" or "the Agency") Office of Prescription Drug Promotion (OPDP) issued three warning and seven untitled letters ...

News

Will FDA be Forced to Implement a Drug Importation Program?

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.”...

News

Court sides with FDA on “same surgical procedure,” “homologous use” for cell and tissue products

On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug Administration’s (FDA) motion for summary...

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