article thumbnail

Regulatory Due Diligence Becomes More Critical in a “Hot” Year for Deals in the FDA Space

FDA Law

Claud — As the calendar turned to 2024, we came across the usual end-of year looks back and projections ahead. Moreover, it requires not only an understanding of what the laws say, but how what the government would be expected to do in the future based on the regulatory compliance history. By John W.M.

article thumbnail

Would I FIE to You? FDA’s First Interchangeable Exclusivity Determination Results in Expiration

FDA Law

Notably, the purpose of the statute seemed to govern much of FDA’s interpretation. The first commercial marketing of each, according to the biosimilar patent settlement agreement, was July 1, 2023, which would render the FIE expiration date July 1, 2024. This all sounds complicated, I know.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Rewiring the body clock: Deep brain imaging reveals unexpected complexity in jet lag adjustment

Medical Xpress

This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding. But what we observed was much more complicated." But technical limitations have made it hard to understand how neurons in this area form functional circuits." Some SCN neurons were activated by light, while others were inhibited.

Provider 111
article thumbnail

NIH to Fund $10M in Long-Term Health Studies After Ohio Train Disaster

Physician's Weekly

Residents of East Palestine, Ohio, where the derailment occurred, have pressed the government to do more to answer questions about the mental and physical health effects of the disaster — from post-traumatic stress to cancer. In 2024, the NIH funded six short-term research projects totaling over $1 million.

article thumbnail

What is going on with MAID in Canada? Bill Gardner, Leonie Herx, & Sonu Gaind

GeriPal

A planned expansion of MAID to include people with mental illness was placed on hold until March 2024. ABIM MOC credit will be offered to subscribers in November, 2024. And so now for March, 2024, the government still has said they’re planning to expand it for mental illness conditions.

Illness 144
article thumbnail

Allowing Patients to Die: Louise Aronson and Bill Andereck

GeriPal

Louise 05:02 Yes, well, I don’t know about 2024, but in 2023, yes, it could happen. Alex 15:13 This is really complicated. Eric 42:11 But how much of it is like Winston Churchill, like, democracy is the worst form of government. ABIM MOC credit will be offered to subscribers in November, 2024. Bill 42:22 I did not.

article thumbnail

As Mosquito Season Peaks, Officials Brace for New Normal of Dengue Cases

Physician's Weekly

happen in Puerto Rico, which saw a sharp increase in 2024 , triggering a local public health emergency. In 2024, California saw 725 new dengue cases, including 18 acquired locally, state data shows. Efforts to combat dengue in California became even more complicated this year after wildfires ripped through Los Angeles.