ProRelix Research

JUNE 26, 2023

As per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, […] The post US FDA Medical Device Applications appeared first on ProRelix Research.

Reagent 52

Reagent In-Vitro Cosmetics Drugs 52

pharmaphorum

SEPTEMBER 29, 2022

Kyle helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code.

Development 104

Development Regulation Production Life Science 104

Roots Analysis

AUGUST 15, 2023

In addition to the healthcare industry, other industries, such as food industry, cosmetics industry and enzyme synthesis industry, are also benefiting from the cell free manufacturing process. Although such systems are still plagued with various challenges, these systems continue to improve at a rapid pace.

Protein 52

Protein In-Vitro Production Reagent 52

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

APRIL 19, 2021

The judges also said that changes to the language of the governing Federal Food, Drug, and Cosmetic Act over the last couple of decades did not abrogate the clear statutory definitions. 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

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

XTalks

DECEMBER 5, 2024

By bypassing the cellular barriers common in synthetic biology, Invizyne aims to produce a wide array of commercially valuable chemicals — ranging from active pharmaceutical ingredients and biofuels to food flavors and cosmetics — more efficiently and sustainably.

Reagent 111

Reagent Production Cosmetics Pharma Companies 111