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). This guidance document is still in effect today. products intended for medical purposes).

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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. The Minnesota Hospital Association, as well as some individual hospitals, testified in support of the bill. The bill was laid over for possible inclusion in a future omnibus bill.

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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

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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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. Let’s build a future where healthcare not only heals—it leads.

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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. forthcoming). If you haven’t heard of the Penalty Offense Authority found in Section 5 of the FTC Act, 15 U.S.C. § Chopra & Levine , supra. As we reported here , the U.S. FTC , No. 19-508 (Apr. 768 (2020)).

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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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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. Gonzalez & Lisa M. SCH : LDT, approved by NYS CLEP.

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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. The latest iteration, version 5.0, released in April 2024, marks the first update since 2020.

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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

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

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 23, 2023

Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021). By Sophia R. Gaulkin & Riëtte van Laack — On May 16, the U.S. Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact.

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FDA Law Blog

JANUARY 26, 2022

By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! With apologies to Rob Base and DJ EZ Rock , it took more than “two” to get this Emgality DTC TV commercial right (insert snare drum here please).

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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 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. Comments on the draft guidance must be submitted by Jan.

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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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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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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

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. is rooted in anti-Blackness.

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GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. We begin with a refresher on psilocybinwhat it is, how it might work, what conditions it may help treat (including demoralization), and how its typically administered. It’s there.

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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. SB 93 – PBM Bill What’s in the Bill : SB 93 , sponsored by Sen.

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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.

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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. Koblitz & Karla L. 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." The ad states that patients may pay as little as $5 per dose, 4 times per year.… All of us.

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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? 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. Riley Griffin et al., US Health Officials Urge Moving Pot to Lower-Risk Tier, Bloomberg News (Aug. The governors observed that the U.S. It will not.

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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. 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 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. Durbins letter addresses FDAs capacity to oversee the increasing volume of DTC advertisements, particularly on platforms like social media.

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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. First, it direct[s] all U.S. MedImmune, Inc. Genentech, Inc.,

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