FDA Law Blog

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.

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FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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FDA Law Blog

JULY 17, 2022

An example of such a drug is a single-use vial of an injectable cancer drug that is dosed based upon weight, and therefore might not be entirely used for a lighter weight patient. The manufacturer responsible for paying the refunds will be the company whose NDC is on the label.

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FDA Law Blog

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

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FDA Law Blog

JUNE 22, 2023

He also identified “Next-Generation Home-based Testing Technologies, including new IVDs, Digital Lateral Flow Readers, and Reporting Technologies” as an opportunity to “extend care from the hospital and clinic into the home setting.” This makes seeking clearance of an OTC home test a risky business endeavor.

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FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask.

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FDA Law Blog

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. Draft Guidance III.B.2(e) Draft Guidance III.B.2(d)

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FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle.

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FDA Law Blog

MARCH 31, 2024

The proposed rule extends far beyond the scope of any legislative proposals and would threaten access to reliable tests for children and patients with rare diseases.” He emphasized that FDA regulatory oversight should focus on those tests that pose the highest risk to patients. These are areas where “revenue is modest,” she said.

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GeriPal

MAY 5, 2022

Including more hospital utilization or healthcare utilization, maybe cognitive impairment issues. My own work focuses on hospitalization and health utilization over time. I think that there’s stress and confusion during care, especially hospitalization leading to delirium, less satisfaction. Is that right? Eric: Yeah.

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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. Draft Guidance at 34.

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FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle.

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FDA Law Blog

APRIL 11, 2022

As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. Specifically, FDA criticized the risk calculation formula because it used the total shipment of affected product , which “underestimates the probability of occurrence because the number of products shipped includes devices not in use by patients (e.g.,

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FDA Law Blog

OCTOBER 10, 2022

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Medical information about a patient. Interpretation of Statutory Criteria Under the Final Guidance.

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Annals of Family Medicine

NOVEMBER 20, 2024

2) Those unable to provide abortion care will: a) learn about evidence-based use of mifepristone for abortion care; b) implement supportive referrals for patients seeking abortion care. Setting and Population Studied: The ExPAND 2022-23 cohort supported 3 clinics in the Midwest (1 FQHC, 2 community hospital clinics).

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FDA Law Blog

MARCH 6, 2025

We were struck by the level of detail expected by FDA for processes related to data management, especially for data collected and used early in development to train an initial AI model, which may occur before a manufacturer decides to move forward with device development under design controls. data acquisition device).

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FDA Law Blog

OCTOBER 16, 2024

To that end, FDA approved the MSN ANDA without the modified dosing regimen and with the indication “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. Citing to “[b]inding Circuit law” in Bristol-Myers Squibb v.

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Alabama Academy of Family Physicians

FEBRUARY 19, 2025

Running from February 4 to May 15, this session promises to bring substantial changes to medical consent laws, Medicaid coverage, rural hospital funding, taxation on essential goods, and the transparency of healthcare costs. HB 86 – Rural Hospital Investment Fund Bill What’s in the Bill: Sponsored by Rep.

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FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. HHS would then use MRAP scores in the proposed Hospital Resilient Supply Program (HRSP).

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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. There are a lot of reasons that may explain the massive increase in use of these drugs.

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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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FDA Law Blog

AUGUST 7, 2024

ENTRESTO was approved by FDA in July 2015 “to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.” Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.”

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FDA Law Blog

SEPTEMBER 28, 2022

Valley Hospital, Inc. Approximately six months before the patient’s surgery, the FDA issued a Safety Communication discouraging the use of power morcellation due to the risk that the procedure could spread cancerous tissue in patients with undiagnosed uterine sarcoma. By Steven J. Gonzalez & Jeffrey N. LEXIS 679 (NJ Aug.

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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. James 00:32 Good afternoon.

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FDA Law Blog

OCTOBER 17, 2023

This 2022 draft guidance proposed that certain non-addictive medical products for pain or addiction treatment could be eligible for breakthrough designation, aligning with the Agency’s obligations under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.

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GeriPal

MARCH 24, 2022

But I think just like patients need their own preparation, really it’s the surrogate that we often leave out of these discussions, especially early on. So every transition into the hospital, every transition out of the hospital. And that surrogate as you’re all saying might be in the context of multiple people.

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FDA Law Blog

JANUARY 18, 2024

whether growing or not; its seeds; resin extracted from any part; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. “Marijuana,” subject to the rescheduling recommendation, means all parts of the plant Cannabis sativa L., 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B).

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Alabama Academy of Family Physicians

FEBRUARY 20, 2025

Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. For providers, it is highly encouraged to submit samples from hospitalized patients to a laboratory capable of identifying H5N1 if influenza is confirmed in the inpatient setting and H5N1 is suspected.

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GeriPal

DECEMBER 7, 2023

And so we do see hospital admissions for heat exposure and certainly cardiovascular and respiratory problems related to air pollution with climate change and also cognitive problems. And that’s a good thing to share with an older patient or client that making decisions about your activity. So you can just get it in there.

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FDA Law Blog

MAY 21, 2024

What, if Any, Risk There Is to the Public Health HHS found based on an evaluation of various epidemiological databases for emergency department visits, hospitalizations, unintentional exposures, and overdose deaths that public health risks posed by marijuana are low compared to other drugs of abuse. Basis at 45; NPRM at 44,613.

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GeriPal

OCTOBER 31, 2024

And the reason why I’m choosing is because it’s respiratory virus season and we don’t want our patients to catch their breath. But it feels the same in that I was on call a lot over the summer, and I took care of a lot of people behind those hospital walls. I want to hear Kelly Clarkson, and I want to hear her sing.

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Physicians News Digest

APRIL 2, 2025

By Julie Appleby Tim Winard knew he needed to buy health insurance when he left his management job in manufacturing to launch his own business. Early last year, he had the colonoscopy at a hospital in Elmhurst, Illinois, not far from his home in Addison. Winard said the hospital declined the offer. Then the bill came.

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FDA Law Blog

NOVEMBER 8, 2022

For whose manufacturers who do not intend to continue device distribution, FDA generally does not intend to request market removal of those devices distributed before the applicable EUA termination or guidance withdrawal date. Maisel also discussed disposition of already distributed devices.

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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.

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