Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. But one can only train a phage so much before it has changed, genetically, to the point where it is now considered a different phage to the one the regulator initially approved.

Therapies 138

Therapies DNA Virus Clinical Trials 138

Drug & Device Law

MAY 19, 2023

at *1, by threatening to revoke the license, and jail for at least three years, any West Virginia physician so bold as to prescribe the plaintiff’s FDA-approved drug for its FDA-approved use. Sorsaia , 2023 WL 3211847, at *2. Its] FDA approval allows it to sell mifepristone nationwide. . . . [T]he T]he growing market for mifepristone. . .

FDA Approval 111

FDA Approval Pharmacy FDA Production 111

Drug & Device Law

DECEMBER 29, 2023

Indeed, even the weird alternatives the plaintiff advocated, such as “point of sale” signs and DTC advertising (assuming these were Prop 65 remedies at all), were still FDA-regulated labeling. Alcozar didn’t buy it, since the particular regulations did not even apply to the clinics and health care providers that plaintiffs were targeting.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. You never need an authorization from a licensed professional to buy pork or fireworks. Ogden , 22 U.S.

Regulations 59

Regulations Production FDA FDA Approval 59