FDA Law Blog

SEPTEMBER 11, 2023

This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. Use of the eSTAR template for 510(k)s becomes mandatory on October 1, 2023 (unless exempt as described in the final guidance ). In a statement released at the time, CDRH Director Jeffrey Shuren, M.D.,

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FDA Law Blog

SEPTEMBER 29, 2021

Department of Health and Human Services (“HHS”), which reported that discounted purchases totaled $38 billion in 2020, a 27% increase compared to 2019. Manufacturers may choose not to participate in this program, but the federal government will not reimburse for their outpatient drugs under Medicaid or Medicare Part B if they do not.

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FDA Law Blog

OCTOBER 14, 2021

Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. These clearances are based on short-term (30 day) patient follow up.

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FDA Law Blog

MARCH 1, 2023

FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).

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FDA Law Blog

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).

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FDA Law Blog

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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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FDA Law Blog

OCTOBER 2, 2024

On the other hand, the Draft Guidance states that a significant change to the design of a printed circuit board (PCB) in a multi-parameter physiological patient monitor, with arrhythmia detection alarms for use in a hospital environment, would not be appropriate for inclusion in a PCCP. Change Guidance at 8. Draft Guidance at 34.

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FDA Law Blog

SEPTEMBER 15, 2022

FDA indicates that this guidance is intended to help manufacturers ensure consistent content and format of the statement of identity and strength for all nonprescription drug products, which then will allow consumers to compare products. For both draft guidances, it is unclear what induced FDA to publish these draft guidances now.

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FDA Law Blog

APRIL 11, 2022

As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. During an inspection, FDA learned that Medtronic had opened a CAPA to address complaints of damaged retainer rings in these pumps (more than 74,000 between June 2016 and November 2019, with more than 57,000 reported to FDA as MDRs).

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Physician's Weekly

JUNE 19, 2025

Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary. In January of last year, Cole went to a Walgreens in Appleton, Wisconsin, to get refills on the medication he used to control his asthma. He’d been taking it for years, and he expected to pay about seventy bucks. He left without it.

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The Clinical Problem Solvers

NOVEMBER 6, 2023

Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. Between the years 2019 and 2021, Harrison served as Associate Editor—and later as Managing Editor—of Wear Your Voice Magazine. During this episode, we hear from Da’Shaun L.

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GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. AFP 2019 Gabapentin for chronic neuropathic pain in adults. Tasce: I do.

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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. It’s there.

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FDA Law Blog

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. Remarkably, manufacturers may not dispute a CMS notification.

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Common Sense Family Doctor

FEBRUARY 15, 2025

In 1998, a Letter to the Editor in American Family Physician expressed concerns about the relatively new practice of pharmaceutical advertising directly to patients. The ad states that patients may pay as little as $5 per dose, 4 times per year.… Who could blame a patient for believing the drug doesn’t cost much.

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FDA Law Blog

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.

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FDA Law Blog

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. Koblitz & Deborah L. More than a few have taken far longer—literally decades.

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FDA Law Blog

JANUARY 11, 2022

Specifically, Amarin alleged that Hikma’s label “teaches CV risk reduction” due to “a notice regarding side effects for patients with CV disease” and an absence of a statement that the generic “should not be used for the CV indication….” The Federal Circuit twice reversed the District Court decision at issue in GSK v. Teva from this case.

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FDA Law Blog

JANUARY 11, 2022

Specifically, Amarin alleged that Hikma’s label “teaches CV risk reduction” due to “a notice regarding side effects for patients with CV disease” and an absence of a statement that the generic “should not be used for the CV indication….” The Federal Circuit twice reversed the District Court decision at issue in GSK v. Teva from this case.

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Tiny Physician

OCTOBER 17, 2021

One trial was conducted to find whether it is effective in fever on children post-DPT vaccination, another one on neonatal calf diarrhea (an animal study), and the last one on its effect on patients with Arsenic toxicity (4). Contrary to our beliefs, the second wave came and exposed all the weaknesses of our health system. Dipankar et.

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FDA Law Blog

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.

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FDA Law Blog

OCTOBER 14, 2022

It was January 31, 2020 when the Secretary of the Department of Health and Human Services (HHS) first declared the 2019 Novel Coronavirus (2019-nCoV) outbreak a public health emergency (PHE), pursuant to Section 319 of the Public Health Service Act (see here ). We’re still doing a lot of work on it. But the pandemic is over.

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FDA Law Blog

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. By Dara Katcher Levy & Sara W. Koblitz & Jeffrey N. it is illegal to import. 70,796, 70,800 (Dec. consumers.

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FDA Law Blog

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. Last Thursday, the U.S.

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