article thumbnail

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.”

article thumbnail

Tobacco Issues Awaiting Robert Califf at the FDA

Bill of Health

Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions. Banning Menthol Cigarettes.

FDA 271
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

'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.

COVID-19 310
article thumbnail

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.

FDA 319
article thumbnail

Opill’s FDA Approval: Implications for Pharmaceutical Regulation and Access to Care

Bill of Health

By James René Jolin and Susannah Baruch On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill (norgestrel) as the first daily oral contraceptive available for non-prescription use in the U.S. James René Jolin (JRJ): This recent move by the FDA is one without precedent. It was a long time coming.

FDA 180
article thumbnail

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.

FDA 102
article thumbnail

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.

COVID-19 263