FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. Unlike hospital reprocessing facilities, many clinical laboratories are overseen by laboratory directors who themselves are medical doctors.

Laboratories 81

Laboratories FDA Regulations Licensing 81

Drug Target Review

AUGUST 9, 2024

She began her career as a clinical oncologist before completing doctoral and post-doctoral training in carcinogenesis and tumour biology. The continued evolution of this field will undoubtedly play a pivotal role in the development of new and improved therapies for the benefit of patients worldwide. References Allen, L. Popovich, N.

Science 59

Science Drugs Compliance Drug Development 59

The Pharma Data

APRIL 4, 2023

“Since receiving FDA clearance in 2010, more than 17 million CoolSculpting® treatments have been performed. “Since receiving FDA clearance in 2010, more than 17 million CoolSculpting® treatments have been performed. In addition, 92% of people would like help getting their body ready for summer.

Treatment 40

Treatment FDA Licensing Licensing 40

Codon

JULY 27, 2023

There’s a TV show where a bunch of doctors are walking through a hospital corridor. A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). All the colors had the same brightness.

Therapies 52

Therapies RNA DNA Engineering 52

Codon

JULY 27, 2023

There’s a TV show where a bunch of doctors are walking through a hospital corridor. A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). All the colors had the same brightness.

Therapies 52

Therapies RNA DNA Engineering 52

Codon

JANUARY 21, 2024

We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. But in 2010, this guy participating in a challenge trial in Oxford committed sexual assault and then ran from the law and was a fugitive, while participating in this study.

Vaccine 126

Vaccine Trials Disease Treatment 126

Codon

FEBRUARY 23, 2025

Countries supported by PEPFAR saw HIV cases drop by 52 percent in 2023 compared to 2010, outpacing the 39 percent global decline. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. They’ve created voluntary licensing agreements with six other pharmaceutical manufacturers (Dr.

Clinical Trials 70

Clinical Trials Virus Vaccine DNA 70