FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N.

In-Vitro 81

In-Vitro Regulation Manufacturing Licensing 81

FDA Law Blog

OCTOBER 6, 2023

The amended regulation would read as follows (revisions underlined): In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

In-Vitro 64

In-Vitro Regulation Production Compliance 64

FDA Law Blog

APRIL 19, 2021

As most readers of our blog are aware, the regulatory costs to manufacturers of medical products are much lower if FDA regulates a product as a medical device rather than a drug requiring FDA marketing approval. A third judge wrote an opinion agreeing that the FDA decision on barium sulfate needed to be reversed and remanded to FDA.

Regulation 40

Regulation Production Drugs In-Vitro 40

XTalks

DECEMBER 5, 2024

Trading under the ticker symbol “IZTC,” Invizyne’s shares debuted on the Nasdaq Capital Market on November 13, 2024. billion global SAF market projected by 2032. Since its founding in 2019, Invizyne has focused on developing SimplePath for essential chemical production.

Reagent 111

Reagent Production Cosmetics Pharma Companies 111