Article, Management and Manufacturing

Researchers Propose Solutions to Improve GLP-1 RA Access

Physician's Weekly

JUNE 18, 2025

Other Persistent Barriers & Potential Solutions In another article not presented at the meeting, Stephanie W. GLP-1 agonists are effective treatments for weight management, and although regulatory bodies and medical providers are on the right path, we have a long way to go,” the researchers concluded.

Healthcare Professional

Healthcare Professional Insurance Manufacturing Healthcare

A Chihuahua or a Muffin? FDA Announces Plans for Aggressive Use of Artificial Intelligence

FDA Law

MAY 29, 2025

Another article about CLAT (available here ) suggests FDAs model will continually learn and improve over time. As we recently blogged about here and here , FDA has issued guidance on lifecycle management for AI-enabled device software functions.

Manufacturing

Manufacturing Patient-Centered Medical Management

Quiet on the Set? Forbidding FDA To Take Photographs During An Inspection Can Be Regrettable

FDA Law

DECEMBER 1, 2024

The current Warning Letter was issued to a drug manufacturer in China (Tianjin Darentang Jingwanhong Pharmaceutical Co., Management, according to the Warning Letter, “stated that the investigators were not allowed to take photographs of the equipment as part of the inspection.”

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How to Start Virtual Care the Right Way: A Proven Roadmap for 2025 and Beyond

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ACI’s 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care

FDA Law

MARCH 9, 2025

This event provides a comprehensive guide to the latest developments affecting articles intended for cleansing, beautifying, promoting attractiveness, or altering the appearance.

Manufacturing

Manufacturing Specialization Provider Management

HPM Grows Its Ranks of Directors, Counsel, and Associates as it begins its 45th Anniversary Year

FDA Law

JANUARY 16, 2025

While HPM prides itself on being the largest dedicated FDA law firm in the United States, it is small by design, so it is the quality of each of these individuals and what they contribute to the firm that is most exciting, said HPM managing Director J.P. She already has broad-based exposure to a variety of FDA regulated products.

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Ep. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. Adler, J.D., of Roetzel & Andress

Physician's Practice

JUNE 9, 2025

Financial Relationships with Pharmaceutical Companies (00:20:10)** Legal and ethical concerns for physicians with financial ties to GLP-1 drug manufacturers, including anti-kickback laws. Reynolds Published: June 2nd 2025 | Updated: June 2nd 2025 Article Your weekly dose of wisdom from the Physicians Practice experts. Adler, J.D.,

Management

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.

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Provider Medical Manufacturing Consulting

The FTC Resurrects Its Penalty Offense Authority in a Big Way

FDA Law

OCTOBER 19, 2021

Moore & Riëtte van Laack — Last fall, when AMG Capital Management, LLC v. Supreme Court in AMG Capital Management, LLC v. As we reported here , the U.S. FTC , No. 19-508 (Apr.

IT

IT Management Appointment Manufacturing

Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

MARCH 2, 2023

I could go on and on, but listen to the podcast instead and for a deeper dive, take a look at the following articles and studies: Gabapentin in the Perioperative setting: Prolonged use of newly prescribed gabapentin after surgery. 2022 Perioperative Gabapentin Use in Older AdultsRevisiting Multimodal Pain Management JAMA IM.

Patient-Centered

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Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

MAY 8, 2025

And it kind of made its way into medicine probably around, I’m going to say the 50s after there was a fairly interesting Time Life article that was published. And when that article went to print, it just went ballistic. Gordon Alwasa. Am I saying that right? I always get. So I can say anything I want. So 5ht2 was.

Illness

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Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

DECEMBER 7, 2023

And on that, I found a link to this article by Rick Moody called Elders in Climate Change, No Excuses, in which he argues that elders are the group that benefited most from the massive consumption of fossil fuels in the post World War II eras. What’s our role in changing the healthcare system, in our own healthcare system.

Healthcare

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‘MAHA Report’ Calls for Fighting Chronic Disease, but Trump and Kennedy Have Yanked Funding

Physician's Weekly

JULY 3, 2025

Spokespeople for the White House and Department of Health and Human Services did not respond to questions for this article. .” His commission is now working on a plan of action. Studies Derailed The MAHA report says environmental chemicals may pose risks to children’s health.

Chronic Disease

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Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

FDA Law

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

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Primary Care Digest

Researchers Propose Solutions to Improve GLP-1 RA Access

A Chihuahua or a Muffin? FDA Announces Plans for Aggressive Use of Artificial Intelligence

Webinars

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Quiet on the Set? Forbidding FDA To Take Photographs During An Inspection Can Be Regrettable

Webinars

ACI’s 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care

HPM Grows Its Ranks of Directors, Counsel, and Associates as it begins its 45th Anniversary Year

Ep. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. Adler, J.D., of Roetzel & Andress

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

The FTC Resurrects Its Penalty Offense Authority in a Big Way

Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

‘MAHA Report’ Calls for Fighting Chronic Disease, but Trump and Kennedy Have Yanked Funding

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

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