pharmaphorum

SEPTEMBER 29, 2022

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. If so, developers must develop and execute on a regulatory strategy. Food and Drug Administration (FDA) regulation as a medical device.

Development 99

Development Regulation Production Life Science 99

Roots Analysis

AUGUST 15, 2023

It is worth mentioning that the first reconstituted system, Protein Synthesis Using Recombinant Elements (PURE) , was developed in 2001. 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.

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.

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81

FDA Law Blog

OCTOBER 6, 2023

Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). FDA notes that it would consider issuing enforcement discretion policies for labs developing LDTs during the early phase of any future public health emergencies. By Allyson B.

In-Vitro 64

In-Vitro Regulation Production Compliance 64