FDA Law

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” . In this post, we focus on the proposed changes themselves, and the many questions the agency leaves unanswered.

Provider 64

Provider Manufacturing IT Medical 64

FDA Law

JANUARY 26, 2022

By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! With apologies to Rob Base and DJ EZ Rock , it took more than “two” to get this Emgality DTC TV commercial right (insert snare drum here please).

IT 40

IT Education Utilities Patient-Centered 40

FDA Law

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction.

Medical 53

Medical Diagnosis Healthcare Clinic 53