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.” use in education, construction, art, and jewelry). FDA does regulate 3D printing equipment and activities when intended to produce regulated medical devices (i.e.,

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Minnesota Academy of Family Physicians

MARCH 27, 2025

SENATE EDUCATION POLICY COMMITTEE S.F. 1354 ( Senator Boldon ): On Wednesday, March 19, 2025, the Senate Education Policy Committee heard S.F. Questions revolved around rates for the different types of Medicare plans, enrollment periods and qualifications for enrollment. 1354, which would establish a School Health Advisory Committee.

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The Medical Futurist

JUNE 21, 2025

The situation today is as follows: One company manufactures software for the radiology department which use a certain format of AI in their daily work. Another company’s algorithm works with the hospital’s electronic medical records, and yet another third-party suplier creates AI to compile insurance reports.

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FDA Law Blog

JUNE 24, 2024

The event, titled “New and Improved – AMCP Format for Formulary Submissions v5.0,” aims to educate pharmaceutical manufacturers and other healthcare stakeholders on the latest updates and best practices in dossier development. will delve into the specifics of the new and improved Format v5.0.

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My Green Doctor

MAY 3, 2025

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. My personal advocacy project is the problem of single use eyedrops.

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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

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. My personal advocacy project is the problem of single use eyedrops.

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The Medical Futurist

JUNE 21, 2025

While it is really difficult to manufacture a contact lens, which is one-third of a millimetre in diameter, a 3D printer sandwiches together different layers of interacting material, which makes it easier to match tiny pieces. and a specificity of 95.5%. The use of Orca Health’s EyeDecide could bring exactly this result.

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FDA Law Blog

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. issues with the design, manufacturing, and components of the device).

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FDA Law Blog

JULY 7, 2022

By Riëtte van Laack — On June 14, 2022, the Senate Health, Education, Labor and Pensions Committee voted to pass the FDA Safety and Landmark Advancements (FDASLA) Act ( S.4348). While FDASLA focuses on user fees and includes several other provisions regarding drugs and devices, it also includes provisions related to cosmetics.

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FDA Law Blog

MAY 30, 2022

As COVID raged, FDA understandably postponed many GMP (Good Manufacturing Practice) and “Bi-Mo” (Bioresearch Monitoring, usually of sponsors of clinical trials or clinical trial sites) on-site inspections. Less understandably, FDA performed very few remote inspections over the last two years (see prior blogposts here, here, and here).

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FDA Law Blog

MAY 23, 2023

Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021). We expect to see comments urging FDA to act against the industry practice of intentionally adding sesame to foods, but it is unclear what actions FDA could take without interfering with manufacturers’ choice over the ingredients in their products.

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FDA Law Blog

JUNE 28, 2023

If a device manufacturer chooses to use an ASCA-accredited testing laboratory to conduct testing for premarket submissions to the FDA, the device manufacturer includes an ASCA declaration of conformity, an ASCA Summary Test Report and a cover letter that indicates that the submission contains ASCA testing as part of their premarket submission.

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FDA Law Blog

DECEMBER 8, 2022

ingredients processed using technology that reliably produces a protein-free ingredient and for which the manufacturer can ensure that the ingredient does not contain protein); Foods in which a major food allergen has been unintentionally incorporated due to cross-contact; and.

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CDOCS

MAY 4, 2021

Being able to communicate our patient's problems in the third dimension always breaks down barriers to case acceptance as the information gleaned via a CT scan is invaluable for both planning and educating the patient. The manufacture of a screw-retained or cementable implant crown and Atlantis abutments comes with a significant cost savings.

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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

OCTOBER 19, 2021

The Commission’s first such Notices under the resurrection went out on October 6, 2021 to 70 for-profit educational institutions.

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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.

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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

Nick: More than obesity, more than education, that’s the one that people pay attention to. Meg: Well, I would argue that for several reasons, you really need good consumer education, where you’re talking about trying to give input on the incorporateness of labels. 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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The Clinical Problem Solvers

NOVEMBER 6, 2023

The developing attitudes about food scarcity and deficit models, and mass media’s manufacturing consent, has to be challenged, especially because there is a deep and rich history of Black people as farmers, gardeners, and ranchers that belies what Chimamanda Ngozi Adichie calls the danger of a single story. Da’Shaun L.

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Alabama Academy of Family Physicians

FEBRUARY 19, 2025

The bill also requires the Alabama Statewide Area Health Education Center Program Office to administer and verify the eligibility of physicians claiming the credit and mandates an evaluation of the program’s success during the 2030 fiscal year.

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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. Enter the FDA’s Center for Veterinary Medicine (“CVM”). And CVM certainly exercises that authority.

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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 typically, in the education around facilitating those conversations, we’re focused on eliciting goals and what are that individual’s goals of care and how does that direct the plan right now, knowing that some of those decisions, even if you make a choice now aren’t actually going to come into play for days, weeks, months.

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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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Doctors for America

MAY 15, 2025

during yesterday’s Senate Health, Education, Labor and Pensions (HELP) Committee hearing. Americans are also increasingly unsafe as Kennedy has dismissed technical staff who inspect and ensure safety of facilities manufacturing drugs and goods. Kennedy Jr.

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FDA Law Blog

DECEMBER 14, 2023

Authorized cannabis activities in those states, the governors wrote, have delivered $15 billion in tax revenue for education, law enforcement and other historically underfunded programs. In other words, a prescription written by a DEA-registered, state-licensed practitioner.

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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

Even if otherwise truthful, the promotion of off-label uses of hormones-including through informal campaigns like those conducted by sales reps or under the guise of sponsored continuing medical education courses-run afoul of the FDAs prohibitions on misbranding and mislabeling. A pre-enforcement challenge is not the only option, of course.

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