pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.

Development 104

Development Regulation Production Life Science 104

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. 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 ). Gaulkin & Jeffrey N.

In-Vitro 81

In-Vitro Regulation Manufacturing Licensing 81

Advarra

OCTOBER 1, 2024

Supplies and materials: These include costs for medical supplies (like drugs, medical devices, and other trial-related materials) and laboratory supplies (such as reagents, kits, and other materials for laboratory activities). This often requires using specific electronic data capture systems and adhering to strict protocols.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

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

Advarra

NOVEMBER 29, 2022

However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines. Taken together, these initiatives offer more frequent interactions between sponsors and regulators to communicate and discuss technological advances.

Gene Therapy 52

Gene Therapy Gene Production Clinical Trials 52

FDA Law Blog

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. Labeling Special Controls The labeling may seem like the easiest Special Control for demonstrating compliance. Here we have broken out the requirements for the Indications for Use, Quick Reference Instructional Sheet, and Device Labeling.

Reagent 40

Reagent Genetics Contamination Marketing 40

FDA Law Blog

AUGUST 3, 2022

Thirty years ago today, FDA announced that it had the authority to regulate you. If anything, the announcement was remarkably inconspicuous: a seemingly throwaway sentence in a draft compliance policy guide for research use only and investigational use only products. By Jeffrey N. Gibbs & Allyson B. 92P-0405 (Aug.

In-Vitro 98

In-Vitro Regulation Production Compliance 98