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“The physician–patient encounter is health care’s choke point” -NEJM

A Country Doctor Writes

We provide many more services over the phone and virtually and we have a whole division for preventative care. We provide many more services over the phone and virtually and we have a whole division for preventative care. Most medical practices are still stuck doing piecework. 1) Healthcare is not at all customer centered.

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Oregon-based medical group Northwest Permanente announces affiliation with The Permanente Medical Group of Northern California

Permanente Medicine

Affiliation will allow groups to drive high-value care and innovation PORTLAND, ORE, April 16, 2025 – Oregon-based Northwest Permanente (NWP) and The Permanente Medical Group (TPMG) of Northern California announced a formal affiliation today. TPMG comprises nearly 10,000 physicians in 116 specialties, providing care for 4.6

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FDA Knows Its Own Strength—and It Includes Concentration

FDA Law

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. To Boehringer’s first and most significant argument, that Congress intended the terms “strength” to match FDA’s interpretation in 2009—prior to the codification of the definition in 21 C.F.R.

IT 59
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Biden Administration Facing Renewed Pressure to Legalize Cannabis

FDA Law

As a reminder, cannabis remains a schedule I substance under the federal Controlled Substances Act (“CSA”), which by definition means it does not have an accepted medical use in treatment in the United States and thus cannot be legally sold or marketed for any purpose. Cole providing guidance to U.S. 21 U.S.C. § 812(b)(1).

Medical 96
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Episode 148: Antiracism in Medicine Series Episode 4 – Dismantling Race-Based Medicine Part 2: Clinical Perspectives

The Clinical Problem Solvers

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. 13:16 Status of the current conversation on removing race from eGFR calculators: why is it so contentious?

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From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious

FDA Law

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” In February 2010, an oral formulation of BRAVECTO, a medication to treat and prevent fleas and tick infestation in dogs, was the subject of an INAD submitted to the Agency.