FDA Law

NOVEMBER 29, 2023

See our prior blog post on the topic here. Risk-based This guiding principle ensures risk management principles are used to evaluate the individual and cumulative changes over the life of the device. If the change does not meet specified performance criteria, it will not be implemented under the PCCP.

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Management Manufacturing Medical Healthcare 115

FDA Law

JULY 10, 2025

The warning must “be placed in a prominent and reasonably visible location” and “have sufficiently high contrast with the immediate background to ensure the warning is likely to be seen and understood by the ordinary individual under customary conditions of purchase and use.” What Made the List? Preservatives such as BHA and BHT.

Manufacturing 66

Manufacturing Chronic Disease Government Provider 66

FDA Law

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. Background.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law

JANUARY 5, 2025

We described the 2022 proposed rule and the ten-plus year history leading up to its issuance in our blog post here. At the same time, if the RLD prescription drug and its generics have gone away, these individuals would not be able to obtain the medication by prescription from their healthcare provider.

Provider 59

Provider Healthcare Individual Manufacturing 59

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! In defending the complete broadcast, Lilly called out similar elements from each of the individual components as demonstrating its intent to have all three viewed sequentially.

IT 40

IT Education Utilities Patient-Centered 40

FDA Law

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

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