FDA Law

OCTOBER 2, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. By Adrienne R. Draft Guidance at 34. As described, this change would not appear likely to introduce a new risk, making it unclear why it could not be implemented via a PCCP.

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Medical Specialization Manufacturing IT 59

FDA Law

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. Combination products are sharing the digital moment with those classified solely as medical devices.

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Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

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. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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Manufacturing Engineering Medical IT 64

FDA Law

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.,

Medical 40

Medical Management Manufacturing Patients 40

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

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.

Patients 64

Patients Medical Provider Manufacturing 64

FDA Law

MAY 3, 2021

DEA seeks to prevent, detect and eliminate the diversion of controlled pharmaceuticals while ensuring their availability for legitimate medical, scientific and industrial purposes. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

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Management Manufacturing Specialization IT 52

FDA Law

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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Supply Chain Manufacturing Physicals Healthcare 52

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

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?

IT 102

IT Screening Hospital Clinic 102

FDA Law

MAY 3, 2021

DEA seeks to prevent, detect and eliminate the diversion of controlled pharmaceuticals while ensuring their availability for legitimate medical, scientific and industrial purposes. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

Management 40

Management Manufacturing Specialization IT 40

Annals of Family Medicine

NOVEMBER 20, 2024

Context: The ExPAND Mifepristone (ExPAND) learning collaborative is a year-long program focused on growing the pool of abortion providers by integrating medication abortion into primary 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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Primary Care Clinic Referral Manufacturing 130

FDA Law

MARCH 6, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. For non-AI-enabled devices, the early feasibility research may not directly affect the development process, i.e., the final, finished device can be fully developed, transferred to a controlled manufacturing environment, and tested under a design controls process.

Manufacturing 105

Manufacturing Management Clinical Practice Clinic 105

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.

Insurance 130

Insurance Management Hospital Vaccination 130

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. Nisha: Thank you so much.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

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

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).

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

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.

Illness 107

Illness IT Patient-Centered Patients 107

FDA Law

SEPTEMBER 28, 2022

Valley Hospital, Inc. 25, 2022), [link] , considered whether a provider’s use of a medical device that is the subject of an FDA safety communication constitutes per se evidence of wanton disregard, which would warrant punitive damages. Gonzalez & Jeffrey N. LEXIS 679 (NJ Aug. by obtaining appropriate informed consent).

Provider 59

Provider Hospital Manufacturing Patients 59

FDA Law

JANUARY 18, 2024

FDA found that marijuana continued to have a high potential for abuse, lacked accepted safety for use under medical supervision and had no currently accepted medical use in treatment in the United States. Schedule I drugs have a high potential for abuse and no currently accepted medical use in treatment in the U.S. 21 U.S.C. §

Medical 69

Medical Physicals IT Healthcare Professional 69

GeriPal

MARCH 24, 2022

And I don’t think necessarily, that appointment needs to be a medicalized process. 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.

Illness 72

Illness IT Healthcare Patient-Centered 72

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 it is going to affect, if it hasn’t already, our food quality, the food that’s available, our medications. Ruth: Right. Ruth: Yeah.

Healthcare 129

Healthcare IT Education Community 129

FDA Law

MAY 21, 2024

The 2016 reviews concluded that marijuana continued to meet schedule I criteria for having a high potential for abuse, no currently accepted medical use in treatment in the U.S., and lacked accepted safety for use under medical supervision. Currently Accepted Medical Use in Treatment in the U.S. 21 U.S.C. § 21 U.S.C. §

Physicals 69

Physicals Medical Clinic Emergency Room 69

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. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. For the public, cautious monitoring is recommended.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

GeriPal

OCTOBER 31, 2024

Alex 00:23 And we’re delighted to welcome Peter Chin-Hong, who is an infectious disease physician and medical educator, professor at UCSF and associate dean for regional campuses. 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.

Vaccination 127

Vaccination IT Patient-Centered Patients 127

FDA Law

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF).

Manufacturing 59

Manufacturing Medical Patient-Centered Provider 59

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. We were so nervous about not being on a company-provided plan,” Winard said.

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Insurance Screening Hospital Patient-Centered 52