FDA Law

SEPTEMBER 22, 2024

See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. SCF : LDT, unmet need within an integrated healthcare system. By Steven J. Gonzalez & Lisa M.

Manufacturing 64

Manufacturing Electronics Provider Management 64

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

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. Whether academic medical centers should be treated differently than other laboratories offering LDTs.

Provider 64

Provider Manufacturing IT Medical 64

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. In discussing these revisions, FDA clarified that an ACNU failure must be reported even if the failure does not cause or lead to inappropriate medication use or consumer harm.

Provider 59

Provider Healthcare Individual Manufacturing 59

FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.

Manufacturing 45

Manufacturing Engineering Clinic Provider 45

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. By Philip Won & Lisa M.

Medical 53

Medical Diagnosis Healthcare Clinic 53

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. § 820.198).

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. While that observation is intended as praise for the TAP Pilot, it can be considered a sad commentary on the general state of manufacturer-CDRH interactions.)

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

FDA Law

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Most OTC drugs, particularly drugs that have been around for a while, are primarily marketed pursuant to OTC monographs.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

FDA Law

SEPTEMBER 8, 2022

Recognizing the problems that high prescription drug costs pose to patient access to medications, many drug manufacturers have created copay assistance programs to help patients afford the copays and deductibles for their medications. These prohibitions are often referred to as copay accumulator adjustment programs.

Insurance 83

Insurance Patients Manufacturing Patient-Centered 83