pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. General Wellness Products. Mobile Medical Applications.

Development 104

Development Regulation Production Life Science 104

Roots Analysis

AUGUST 15, 2023

These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products. Such systems provide control over the components used for the synthesis of target products making it easier to manipulate the contents according to specific needs.

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

FDA , the Court of Appeals ruled that FDA cannot regulate a medical product – in this case, the radiographic contrast agent barium sulfate – as a drug when the product meets the definition of a device. The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products.

Regulation 40

Regulation Production Drugs In-Vitro 40

FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R.

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. billion global SAF market projected by 2032.

Reagent 111

Reagent Production Cosmetics Pharma Companies 111