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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

FDA proposes annual summary reporting requirements for Right to Try drug sponsors, manufacturers

On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational...

News

FDA quietly withdraws plans for a Devices Referencing Drugs regulatory approval pathway

The U.S. Food and Drug Administration recently withdrew its plans for a “Devices Referencing Drugs” (DRD) regulatory approval pathway, which it had proposed in September 2017....

News

HHS offers flexibility on human subjects protection regs during COVID-19 pandemic

On April 8, the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) issued guidance discussing how HHS human subjects protection...

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

FDA creates Coronavirus Treatment Acceleration Program to speed COVID-19 therapy development

The U.S. Food and Drug Administration (FDA) on March 31 announced the establishment of a special emergency program to help speed actions on possible COVID-19 therapies. The Coronavirus...

News

In midst of COVID-19, FDA reminds industry that it plays both good and bad cop

U.S. authorities are actively policing entities making illegal promotional claims that products mitigate, prevent, treat, cure, or diagnose COVID-19. To date, seven Warning Letters...

News

FDA permits waivers of some REMS-required laboratory tests, imaging studies due to COVID-19
Registered Content

On March 22, the U.S. Food and Drug Administration (FDA) published the guidance “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency,” in which the...

News

FDA eases some postmarket adverse event reporting deadlines during COVID-19 pandemic
Registered Content

During the ongoing COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) expects that workforces will be reduced at the same time that the use of medical products will increase....

News

COVID-19’s impact on clinical trials prompts FDA to issue guidance to assist with study conduct
Registered Content

On Wednesday, March 18, the U.S. Food and Drug Administration published the guidance“Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic." The guidance...

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