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. licensure of a cholera vaccine in 2016, established correlates of protection for influenza that same year, and helped accelerate approval of paratyphoid vaccines in 2019.

Vaccine 111

Vaccine Trials Disease Virus 111

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

Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. There is also a growing body of successful treatments in the U.S., Phage therapies are sold at a pharmacy in Georgia.

Therapies 118

Therapies Virus DNA Clinical Trials 118

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

The Pharma Data

MAY 13, 2021

Description: How A Handsome Doctor From Texas Saved My Life. I could hear doctors and nurses speaking in hushed tones…. I gave up carbs, fats, alcohol, meat – just as the doctor ordered…. My dear old doctor told me that hormone testing is expensive and unnecessary…. My doctor said it was all simple math….

Production 52

Production Packaging Doctors Research 52

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

There has been no evidence that marijuana’s schedule should change since the last rescheduling review in 2016. Rescheduling would eliminate a tax burden on cannabis companies, allowing licensed companies to expand investments into state programs and focus on public health in collaboration with law enforcement efforts.

Regulations 59

Regulations Production FDA Approval Marketing 59