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. The FDA’s General Approach to Regulating mHealth Products.

Development 97

Development Regulation Production Life Science 97

Roots Analysis

AUGUST 15, 2023

Overview of Cell Free Systems Cell-free systems are ­in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells. It is worth mentioning that the first reconstituted system, Protein Synthesis Using Recombinant Elements (PURE) , was developed in 2001.

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 ).

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). There is much to unpack, and we intend to do so in a series of blog posts. In this post, we focus on the proposed changes themselves, and the many questions the agency leaves unanswered.

In-Vitro 64

In-Vitro Regulation Production Compliance 64