Blog, Individual, Manufacturing and Patients

eMDR System Enhancements

FDA Law

MARCH 8, 2023

Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. User facilities are not required, but have been encouraged, to submit MDRs electronically.

Electronics

Electronics Manufacturing Provider Medical

Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

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

Manufacturing Patient-Centered Healthcare Utilities

D.C. Court Strikes Down Copay Accumulator Rule

FDA Law

OCTOBER 9, 2023

We previously blogged about this lawsuit last year. The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. Once an individual reaches this annual cap, the insurer is solely responsible for covering the individual’s remaining medical expenses that year.

Insurance

Insurance Manufacturing Patient-Centered Individual

Webinars

How to Start Virtual Care the Right Way: A Proven Roadmap for 2025 and Beyond

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Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law

OCTOBER 14, 2024

At the clinics, Defendants offer treatments that consist of extracting fat tissue from patients and, through a multi-step process, turning that tissue into a liquefied mixture of stem cells, other cells and cell debris known as Stromal Vascular Fraction (SVF). HCT/Ps that meet the four criteria under 21 CFR 1271.10(a),

Clinic

Clinic Patient-Centered Asthma Patients

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered

Patient-Centered Manufacturing Clinic Provider

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law

OCTOBER 10, 2022

You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information. Medical information about a patient.

Clinic

Clinic Medical Provider Patients

It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

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

IT Education Utilities Patient-Centered

Well Isn’t that Special: An Assessment of the Special Control Associated with Simple Point of Care COVID-19 Antigen Tests

FDA Law

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. In addition, similar to what was required for an EUA, sponsors should evaluate cybersecurity of their system to ensure user and patient safety in the intended use environment.

Specialization

Specialization Clinic Provider IT

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

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

Manufacturing Physicals Provider Electronics

A Reversal on Sequencing? Proposed Legislation Would Allow Patenting of Naturally Occurring Genes

FDA Law

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. Javitt & Jeffrey N. The concerns raised by PERA are not limited to these industries, however.

Manufacturing

Manufacturing Clinic IT Vaccination

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

FDA Law

OCTOBER 17, 2023

In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog. FDA will consider if technologies and device features “address unmet needs in these populations” when evaluating criterion one.

Medical

Medical Diagnosis Healthcare Clinic

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA Law

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

Manufacturing

Manufacturing Vaccination Government Diagnosis

FDA-Approved Labeling: Is Enough Enough?

FDA Law

AUGUST 21, 2023

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. A recent state law failure-to-warn case in the SDNY makes that very point.

Manufacturing

Manufacturing Consulting Healthcare Professional Vaccination

Patient Groups Sue HHS, CMS for 2020 Rule Allowing the Use of Copay Accumulator Programs

FDA Law

SEPTEMBER 8, 2022

Wasserstein — Three patient advocate groups have sued the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), challenging HHS’s 2020 Notice of Benefits and Payment Parameters (NBPP) rule. The patient, on the other hand, is no closer to meeting their deductible than before.

Insurance

Insurance Patients Manufacturing Patient-Centered

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

FDA Law

MAY 13, 2025

Wasserstein We are still parsing through the May 12 Executive Order (EO), Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients and impacts this may have on the pharmaceutical industry. Weve blogged about Most-Favored-Nation (MFN) drug pricing and how the new EO goes well beyond the 2020 order and questions we have.

Manufacturing

Manufacturing IT Provider Individual

Most Favored Nation Pricing is Back – With a Vengeance

FDA Law

MAY 12, 2025

Kirschenbaum On September 15, 2020, I posted an article in this blog entitled Trump Embraces International Reference Pricing in Executive Order, which described an order in Trumps first administration to use most-favored-nation (MFN) pricing as a limit on Medicare payment. Within 30 days (i.e., Within 180 days (i.e.,

Manufacturing

Manufacturing Provider Patients IT

Primary Care Digest

eMDR System Enhancements

Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

Webinars

Trending Sources

D.C. Court Strikes Down Copay Accumulator Rule

Webinars

Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

Well Isn’t that Special: An Assessment of the Special Control Associated with Simple Point of Care COVID-19 Antigen Tests

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

A Reversal on Sequencing? Proposed Legislation Would Allow Patenting of Naturally Occurring Genes

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA-Approved Labeling: Is Enough Enough?

Patient Groups Sue HHS, CMS for 2020 Rule Allowing the Use of Copay Accumulator Programs

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

Most Favored Nation Pricing is Back – With a Vengeance

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