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

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 111

Vaccine Trials Disease Treatment 111

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

Drug & Device Law

AUGUST 8, 2022

Apparently, a fraudulent foreign-trained “doctor” treated the plaintiffs, none of whom claimed malpractice or any physical injury whatsoever. Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. 23 in its current form. at *3) Rule 23(c)(4) partial class.

Production 52

Production Doctors Licensing Licensing 52