FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

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The Medical Futurist

JUNE 21, 2025

Researchers say that the implant cannot provide any highly detailed vision – but it can help patients detect distinct patterns such as door frames and shapes. The journal Nature provided a commentary report on HKUST’s research into the bionic eye. The paper, recently published in PLOS , summarises three years of data.

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Diabetes Patient-Centered IT Patients 98

My Green Doctor

MAY 3, 2025

The breadth of services provided by modern day medicine is profound. Organizations such as EyeSustain and My Green Doctor are educating clinicians and practice managers on ways to reduce medical waste and are promoting research on this topic. The product manufacturers and vendors will need to be active partners as well.

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FDA Law Blog

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. By Steven J. Gonzalez & Lisa M.

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FDA Law Blog

AUGUST 23, 2021

Kirschenbaum — On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of a revised PhRMA Code on Interactions with Health Care Professionals , which takes effect on January 1, 2022. By McKenzie E. Cato & Alan M. not friends, significant others, or family members of a speaker or invitee).

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My Green Doctor

MAY 3, 2025

The breadth of services provided by modern day medicine is profound. Organizations such as EyeSustain and My Green Doctor are educating clinicians and practice managers on ways to reduce medical waste and are promoting research on this topic. The product manufacturers and vendors will need to be active partners as well.

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FDA Law Blog

JUNE 28, 2023

As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted. The MDUFA V reauthorization converts the ASCA Pilot to a permanent program.

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CDOCS

MAY 4, 2021

We need to recognize how clinical dentistry has become intertwined with digital technologies to synergistically assist us in providing enhanced diagnosis with safe and predictable treatment outcomes. & The manufacture of a screw-retained or cementable implant crown and Atlantis abutments comes with a significant cost savings.

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Patient-Centered Patients Manufacturing Clinic 52

FDA Law Blog

DECEMBER 8, 2022

In addition to providing additional examples of tree nuts, the draft guidance states that FDA considers the following categories of fish to be major food allergens under Section 201(qq): Jawless fish (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023, sesame. trout); and.

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Engineering Transportation Manufacturing Education 59

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.

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FDA Law Blog

DECEMBER 20, 2021

Specifically, the issue is whether this provision applies to bar dietary supplements, such as NAC, that were on the market before the enactment of the Dietary Supplement Health Education Act (DSHEA), in 1994, which added this exclusionary clause into the FDC Act. FDA merely indicated that it was still considering that issue.

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CDOCS

MARCH 15, 2021

You see, we used to be cerecdoctors.com, focusing on just CEREC education, and the magazine was to be a print version that would be sent out quarterly, highlighting the trends with the CEREC system. Our goal is to provide the same engaging, informative, and educational content, only in a digital manner.

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FDA Law Blog

JANUARY 26, 2022

This content is likely one of the reasons for FDA’s withdrawal of the Draft Guidance in 2015 – the same year that FDA suffered one of the most significant blows regarding First Amendment protections for pharmaceutical manufacturer speech.

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GeriPal

MAY 5, 2022

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. So this is a podcast going at the geriatricians and palliative care providers. Nick: More than obesity, more than education, that’s the one that people pay attention to. Hearing aids, you had six big manufacturers of hearing aids.

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FDA Law Blog

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. § 806) and Complaint Files (21 C.F.R.

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Manufacturing Provider Physicals Electronics 64

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

What Happened: Passed out of the House of Representatives HB 46 – Rural Physicians Tax Credit What’s in the Bill: HB 46 terminates the existing Rural Physician Tax Credit program in Alabama, which provided tax credits to physicians practicing in rural areas, effective December 31, 2025.

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FDA Law Blog

JANUARY 3, 2024

A longstanding component of the FDA and its predecessor, CVM, in its initial form as part of the Department of Health, Education, and Welfare, was established in 1965 and evolved in CVM by 1984. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

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Common Sense Family Doctor

FEBRUARY 15, 2025

He argued that "the pharmaceutical industry should concentrate its efforts on educating physicians about its new products, not coercing patients to put pressure on physicians to make decisions that may not be necessary, beneficial or cost-effective." Kennedy, Jr.’s s previously stated intention to ban DTCA from television.

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GeriPal

MAY 8, 2025

Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? 7 out of 10 of these patients said it was one of the top five most educational and meaningful experiences of their entire lives. Do you educate them not to drive?

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GeriPal

MARCH 24, 2022

And I would say too, as a primary care provider, it really doesn’t take that long to ask people about a surrogate decision maker. Certainly, it was the healthcare providers who were looking for a decision, but that was because a decision needed to be made, and sometimes that’s inescapable. Eric: Susan. Susan: Yeah.

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GeriPal

DECEMBER 7, 2023

-@AlexSmithMD Additional links: JAMA paper on clinical research risks, climate change, and health Geriatric medicine in the era of climate change Health Care Without Harm: [link] Practice Green Health: [link] Global Consortium for Climate and Health Education: [link] Transcript Eric: Welcome to the GeriPal podcast. This is Eric Widera.

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FDA Law Blog

JUNE 1, 2025

The bill would also mandate that drug manufacturers report payments to influencers to the federal Open Payments database, similar to current requirements for physicians. Its unclear whether there are truly regulatory gaps that require new legislation.

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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 because MRNA vaccine someone nimbly manufacture, they can say hey, let’s just make a vaccine based on what’s currently circulating.

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FDA Law Blog

MAY 26, 2025

Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care. Department of Health & Human Services purporting to provide a comprehensive review of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria.

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