FDA Law

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. The 2006 guidance noted that these would be “rare cases” limited to “specific issues of urgent concern.”

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Today's Hospitalist

APRIL 24, 2025

Key takeaways: Admission delays from the ED can adversely affect mortality, length of stay, medical errors and quality of care. Those interventions included standardizing both bed assignments and nursing handoffs while having ED providers—not an inpatient team—enter skeletal orders when deciding to admit a patient.

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FDA Law

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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FDA Law

DECEMBER 12, 2022

In an appendix, FDA provides a model “decision check list” for patients. You should place your initials in the location provided next to each item to indicate that you have read and understood the item. It looks similar to the type of procedural informed consent a surgeon ordinarily would present to a patient.

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Manufacturing Provider Patients IT 52

Permanente Medicine

JUNE 3, 2025

Assistant Regional Medical Director, Care Experience Southern California Permanente Medical Group Podcast transcript Transcript is autogenerated. I practice family and sports medicine as part of the Southern California Permanente Medical Group here in Fontana, California. I joined SCPMG straight from residency in 2006.

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IT Patient-Centered Patients Medical 52

GeriPal

MARCH 2, 2023

2006 Transcript Eric: Welcome to the GeriPal Podcast. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US.

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Patient-Centered IT Healthcare Medical 96

FDA Law

MARCH 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). It authorized FDA oversight over mammography facilities.

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