Minnesota Academy of Family Physicians

MARCH 27, 2025

Key proposals included increasing hospital Medicaid reimbursement rates , preventing mid-year changes to prescription drug formularies and establishing a School Health Advisory Committee. 2413 ( Senator Mann ) creates a new assessment on hospitals to increase Medical Assistance reimbursement rates. Read a summary of S.F.

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My Green Doctor

MAY 3, 2025

In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Our Consulting Services offer customized strategies for group practices, health systems, and medical societies ready to accelerate their impact and lead the way in climate-smart care.

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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.

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FDA Law

OCTOBER 2, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. By Adrienne R. Change Guidance at 8.

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Georgetown Pediatrics & Family Medicine

MAY 11, 2022

Watering down formula to stretch it out can cause nutritional imbalances in your baby and lead to serious health problems that require hospitalization. Watering down formula to stretch it out can cause nutritional imbalances in your baby and lead to serious health problems that require hospitalization. Check social media groups.

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 Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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FDA Law

JANUARY 5, 2023

In mid-November, FDA collaborated with the MITRE Corporation to publish an update to the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. Combination products are sharing the digital moment with those classified solely as medical devices. FDA has shown a willingness to intervene in this space.

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Manufacturing Patient-Centered Provider Telehealth 59

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. By McKenzie E. Cato & Jeffrey N.

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GeriPal

MAY 5, 2022

Think about the last time you attended a talk on communication skills or goals of care discussions. Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? I’m guessing not. COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Alex: (Singing).

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FDA Law

MARCH 31, 2022

VBP pricing may be determined by outcomes-based measures, which substantially link a drug’s cost to its actual performance or a reduction in medical expenses, or by evidence-based measures, which substantially link cost to existing evidence of effectiveness and value for a specific use. See 42 C.F.R. 447.505(a), 85 Fed. 87000, 87102 (Dec.

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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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FDA Law

APRIL 11, 2022

As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. Of course, it would not always be true that there is a significant gap between the number of medical devices shipped and the number in actual use. For instance, some products could remain in boxes in hospital inventory for an extended period.

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Medical Management Manufacturing Patients 40

FDA Law

MARCH 31, 2024

Susan Van Meter, the president of the American Clinical Laboratory Association, said, “FDA is poised to reshape the regulation of laboratories by bypassing Congress and unilaterally imposing medical device regulation on the professional testing services that laboratories provide.”

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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. the wholesale distributor, repackager, relabeler). Draft Guidance III.B.2(e)

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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

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.

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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.

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GeriPal

MARCH 2, 2023

Eric: And we have Tasce Bongiovanni, who is an acute care trauma surgeon at UCSF and the San Francisco General Hospital. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. However, most gabapentin prescriptions are written off-label indications.

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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. Here’s a brief overview of the key pieces of legislation that AAFP is diligently monitoring.

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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.

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

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GeriPal

MAY 8, 2025

Vincent’s Hospital in Melbourne, Australia. We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. James, welcome to the GeriPal Podcast. James 00:32 Good afternoon. She’s joining us at 6am her time. Im b leary eyed.

Illness 107

Illness IT Patient-Centered Patients 107

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. §

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Medical Physicals IT Healthcare Professional 69

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. By Steven J. Gonzalez & Jeffrey N. LEXIS 679 (NJ Aug. LEXIS 679 (NJ Aug. Case Summary.

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Provider Hospital Manufacturing Patients 59

GeriPal

MARCH 24, 2022

All decisions are made in advance, the question that we are debating is how far in advance and what to call it. Completion of advance directives and billing codes for advance care planning as quality metrics. Among other topics. We can work it out! Links to a few couple items mentioned on the podcast: Objectives for Advance Care Planning.

Illness 72

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GeriPal

DECEMBER 7, 2023

Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US. My kids ask – why don’t adults care about this issue the same way that they and their friends care about it? Ruth: Thank you.

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. 21 U.S.C. § 21 U.S.C. § 21 U.S.C. § NPRM at 44,619. 21 U.S.C. § NPRM at 44,601.

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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. However, the 68 human cases in the U.S.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

FDA Law

DECEMBER 14, 2023

Quoting a Pew Research poll, the governors expressed their “hope” that DEA reschedules cannabis to schedule III “this year” because 88% of Americans favor legalization for medical or recreational use. As explained more fully explained below, that impression would be partially correct, but partially incorrect.

Medical 59

Medical Manufacturing IT Education 59

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. Lona, welcome back to GeriPal. Lona 00:21 It’s great to be here. Peter, welcome to the GeriPal Podcast. Peter, welcome to the GeriPal Podcast.

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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).

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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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