2019, Individual and Manufacturing

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

Manufacturing

Manufacturing Provider Medical IT

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

Manufacturing

Manufacturing Hospital Healthcare Medical

Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals

FDA Law

JUNE 28, 2021

Under current Minnesota law enacted in May 2019, manufacturers that sell, deliver, or distribute into or within Minnesota 2 million or more units of an opiate are required to pay an annual product registration fee of $250,000.

Hospital

Hospital Manufacturing Specialization Medical

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

FDA Law

NOVEMBER 6, 2022

Pfizer manufactures tafamidis (sold under brand names Vyndaqel and Vyndamax), a breakthrough treatment for a rare, progressive heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Background.

Manufacturing

Manufacturing Patient-Centered Healthcare Utilities

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

FDA Law

OCTOBER 14, 2024

The lowest risk category, which is not subject to any oversight by FDA, includes HCT/Ps removed from an individual that are implanted into the same individual during the “same surgical procedure.” 588, 566 (2019)). HCT/Ps that meet the four criteria under 21 CFR 1271.10(a), Robbins , 519 U.S. 452 (1997); see also Kisor v.

Clinic

Clinic Patient-Centered Asthma Patients

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

Patients

Patients Clinic Medical Patient-Centered

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

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. FDA gives no rationale for interpreting the apparently broad statutory term “medical information” in such a restrictive manner.

Clinic

Clinic Medical Provider Patients

Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. I also heard that if you look at all individuals in the US, about 4% of individuals are taking one of the gabapentinoids, 10% over 65. JAGS 2022 Trends in Antipsychotic and Mood Stabilizer Prescribing in Long-Term Care in the U.S.: Nisha: Both of them are generic, yeah.

Patient-Centered

Patient-Centered IT Healthcare Medical

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

Specifically, the Court explained, because “[t]he Pregnancy Warning Regulation simply does not speak to whether a further warning related to a drug’s use during pregnancy can be added to the general Pregnancy Warning on a drug label, whether added by the FDA or added by a manufacturer,” the ”regulation does not, therefore, preempt state law.”

Manufacturing

Manufacturing Consulting Healthcare Professional Vaccination

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. Almost all.

Illness

Illness IT Patient-Centered Patients

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

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

Insurance Patients Manufacturing Patient-Centered

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

FDA Law

MAY 13, 2025

Section 5 of the May 12 EO states that within 30 days, HHS will communicate MFN price targets to pharmaceutical manufacturers to bring prices for patients in line with comparably developed nations. (We note our departure from more light-hearted content and absence of musical references. Please bear with us.) it is illegal to import.

Manufacturing

Manufacturing IT Provider Individual

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

FDA Law

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

Manufacturing

Manufacturing Supply Chain Patient-Centered Utilities

Primary Care Digest

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

Trending Sources

Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals

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

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

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

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

Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

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

FDA-Approved Labeling: Is Enough Enough?

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

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?

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

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