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. The speaker program should occur in a venue that is conducive to the informational communication.

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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. SCH : LDT, approved by NYS CLEP. It should be noted that 21 CFR 803.18(b)(1)(ii)

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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

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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CDOCS

MAY 4, 2021

I diagnosed this case to be complex, requiring extensive bone regeneration, possibly with multiple grafts and informed this patient of the risks, timeline and complexity of his case. The possible complications were communicated so that the patient could make an informed decision and proceed with treatment.

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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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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

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. Several months later, NPA filed its own CP making the same arguments.

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FDA Law Blog

JANUARY 26, 2022

FDA alleged that because the TV ads contained representations or suggestions relating to Emgality’s indication for use, they were required to include risk information as well adequate provision for the dissemination of the PI or a brief summary as required by 21 C.F.R.

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GeriPal

MAY 5, 2022

And when you think about that, they’re hearing pieces of the information and their brain is trying to make sense of it. Nick: More than obesity, more than education, that’s the one that people pay attention to. It’s because they literally couldn’t access the information. Five big manufacturers.

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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.

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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. The bill also addresses parental access to health information and parental rights.

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The Clinical Problem Solvers

NOVEMBER 6, 2023

Harrison, the work that they do is deeply informed by the history of chattel slavery in the United States, through which eugenicists, white anthropologists, and racial realists created entire disorders to medicalize and bastardize enslaved folks who were interested in freedom. Episode Takeaways Origin Stories – For Dr. Psyche A. Da’Shaun L.

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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

Ideally, there’ll be a place in the chart that actually captures the name of that person and their contact information. So a lot of the skills that are used in advance care planning are the same kind of skills you would use in a context where you were communicating information or prognosis or doing an informed consent discussion.

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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

Commissioner Makary has taken a more subdued stance, stating in a podcast with Megyn Kelly that FDA doesnt have any plans to ban direct-to-consumer advertising, but there are some things that we can do to make sure that the information being presented is a complete picture.

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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. Defenses can also be raised during an investigation.

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