FDA Law

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law

DECEMBER 13, 2022

Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection.

Telehealth 72

Telehealth Patients Manufacturing Transportation 72

FDA Law

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

Electronics 59

Electronics Manufacturing Provider Medical 59

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. One unit equals one tablet, capsule, patch, syringe, milliliter, or gram.” 151.066, Subd.

Hospital 52

Hospital Manufacturing Specialization Medical 52

FDA Law

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” Background.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

Manufacturing 52

Manufacturing Provider Patients Medical 52

FDA Law

OCTOBER 9, 2023

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 40

Insurance Manufacturing Patient-Centered Individual 40

GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

IT 120

IT Patient-Centered Patients Clinic 120

FDA Law

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. 5429, the “ Medication Affordability and Patent Integrity Act.” But it is not always clear which types of patents are eligible for listing in the Orange Book.

Manufacturing 105

Manufacturing Provider IT Healthcare 105

FDA Law

JUNE 22, 2023

Most recently, Jeff Shuren, CDRH Director, gave a speech at the 2023 Food and Drug Law Institute (FDLI) annual conference in which he identified facilitating “availability of and access to existing and novel home-use medical technologies” as a strategic priority for 2022-2023 to advance health equity.

Manufacturing 59

Manufacturing Clinic IT Transportation 59

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 59

Clinic Patient-Centered Asthma Patients 59

FDA Law

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. syringes), to any individual without a patient-specific prescription. plies for administration (e.g.,

Supply Chain 52

Supply Chain Individual Provider Patient-Centered 52

FDA Law

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. Walsh & Sophia R. Gaulkin & Steven J. This scrutiny was enhanced after the Fourth Circuits ruling in United States v. Mallory , 988 F.3d

Referral 59

Referral Relationship Government Healthcare 59

FDA Law

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The CDS Guidance interprets the Cures Act’s definition of “medical software” that is excluded from the statutory “device” definition, as it relates to CDS software.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law

AUGUST 17, 2023

This statutory provision requires generic drugs to have the same labeling as that approved for the listed drug “except for changes required because of differences approved under a [suitability petition, allowing for certain differences] or because the new drug and the listed drug are produced or distributed by different manufacturers.”

Manufacturing 40

Manufacturing IT Medical Individual 40

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 52

Patient-Centered Manufacturing Clinic Provider 52

GeriPal

MAY 5, 2022

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. Communication techniques we can use when talking to individuals with hearing loss. But individuals who have hearing loss, there’s several problems. How to screen for hearing loss.

IT 102

IT Screening Hospital Clinic 102

FDA Law

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. Final Release Criteria Special Controls Sponsors will need to provide the final manufacturing release criterion with evidence that lots released at the extremes of the specification will still meet the claimed device performance (i.e.,

Specialization 40

Specialization Clinic Provider IT 40

Physician's Weekly

JULY 1, 2025

The conference highlighted the latest advances in diabetes research and improving patient care, with presentations focusing on treatment recommendations and advances in management technology. ” The study was funded by MannKind, the manufacturer of Afrezza. As part of the INHALE-1 study, Michael J. Haller, M.D., 1956-LB Felicia L.

Diabetes 52

Diabetes Patient-Centered Management Individual 52

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. It’s not a controlled substance medication. Tasce: Yes. Taylor Swift.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

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

NOVEMBER 18, 2021

Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence of an active SARS?CoV?2 The tests are very accurate in detecting individuals with a relatively high viral load (symptomatic or not). PCR, nor will they perform as well in patients with a low viral load.

Screening 98

Screening Healthcare Manufacturing IT 98

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. 360e-3)).”

Medical 53

Medical Diagnosis Healthcare Clinic 53

FDA Law

JANUARY 8, 2023

The enactment of the Medical Marijuana and Cannabidiol Research Expansion Act (“the Act”) into law (Public Law 117-215) last month is a step in that direction. To date 39 states and the District of Columbia have legalized cannabis for medical use (and 21 for adult recreational use), mainly through ballot initiatives. 21 U.S.C. §

Medical 64

Medical Manufacturing Electronics Provider 64

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. Senate SB 43 – Patient Price Transparency Bill What’s in the Bill: Sponsored by Sen.

Insurance 130

Insurance Management Hospital Vaccination 130

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. Then fast forward a year.

Illness 107

Illness IT Patient-Centered Patients 107

FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

FDA Law

FEBRUARY 22, 2022

We identified as the main culprit FDA’s requirement that these tests achieve 80% sensitivity (positive percent agreement or PPA) even when a required percentage of low positive patients are included. The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data.

Manufacturing 52

Manufacturing Screening Provider Clinic 52

FDA Law

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. and lack accepted safety for use under medical supervision.

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95

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 64

Manufacturing Clinic IT Vaccination 64

GeriPal

MARCH 24, 2022

And I don’t think necessarily, that appointment needs to be a medicalized process. Although, certainly when you start facing complications of serious illness, it is increasingly important to engage as individuals and conversations about goals, values, and preferences. So it sits in this strange in between place. Who are they?

Illness 72

Illness IT Healthcare Patient-Centered 72

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 59

Manufacturing Vaccination Government Diagnosis 59

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 40

Manufacturing Consulting Healthcare Professional Vaccination 40

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

By Wes Stubblefield, MD, MPH, FAAP ADPH Medical Officer H5N1 influenza, or “bird flu,” is a type of influenza that was first discovered in the 1950s. There have been a few severe cases and one individual died with H5N1 infection. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. So it’s hard to know about individual practice when I think of geriatrics or geriatric nursing because a lot of the solutions are really broad scale public health initiatives are needed, don’t you think?

Healthcare 129

Healthcare IT Education Community 129

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 83

Insurance Patients Manufacturing Patient-Centered 83