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Public Health Product Hops

Bill of Health

Dmitry’s talk, “Evergreening: The FDA’s Role in the Creation of Balanced Rights for Pharmaceutical Improvements,” was developed into an article and published in the Iowa Law Review in 2019 titled “The More Things Change: Improvement Patents, Drug Modifications, and the FDA.”

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'Appropriate' transition period for COVID-19 test EUAs when public health emergency ends

Healthcare Dive

The FDA is planning to give holders of EUAs for COVID-19 diagnostics and other devices 180 days notice of its intent to end their authorizations, in anticipation of U.S. public health emergency declarations stopping.

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Pig Hearts for Humans and the FDA

Bill of Health

Food and Drug Administration (FDA) has not approved any genetically modified or pure animal organs for xenotransplantation in humans. For the surgery to go forward in Bennett’s case, the team had to submit a request to the FDA seeking to use the pig heart in the emergency procedure (so-called “compassionate use” ). Categorization.

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Deliberate AI Joins FDA Pilot to Develop Mental Health Treatments

HIT Consultant

What You Should Know: – Deliberate AI , a digital health company harnessing AI to revolutionize mental health assessment, has secured a major milestone in its mission. – The collaboration between Deliberate AI and the FDA represents a giant leap in the fight against mental illness.

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FDA takes N95 respirators off medical device shortage list

Healthcare Dive

Respirators were one of the first medical devices identified as being in critical shortage during the COVID-19 public health emergency, the agency said.

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Eroding Judicial Deference to the FDA — Consequences for Public Health

NEJM

The FDA has long conducted its oversight of prescription drugs and other products with deference from courts. But mounting judicial skepticism of agency authority threatens to upend this norm.

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FDA Selects Aetion Evidence Platform to Assess In-Patient COVID-19 Treatments

HIT Consultant

Food and Drug Administration (FDA) has contracted with them to use their Aetion Evidence Platform® to rapidly assess in-patient COVID-19 treatments and advance regulatory science to help determine when, where and how to use RWD. Enables rapid evidence generation for COVID-19 and future pandemics.