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Risking It All For a New Business Model at Family Physicians of St. Joe

Family Physicians of St. Joseph

In 2007, Dr. Mancini joined the practice, followed by Dr. Meadows in 2012, and Dr. Gendernalik in 2015. The individuals who make up the practice impact the community in a variety of ways. Larger companies now dominate the healthcare landscape, yet through innovation and a dedication to exceptional patient care, Family Physicians of St.

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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog

Pharmacists’ Corresponding Responsibility A controlled substance prescription, to be valid, must be issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” On October 10th, based on ability to pay, the U.S. 11, 2023 ( DOJ Press Release ). 21 U.S.C. §

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Q&A: Cannabis Use Tied to Reduced Working Memory

Physician's Weekly

Gowin and his colleagues analyzed data from 1,003 adults between 22 and 36 years of age who had functional magnetic resonance imaging (fMRI), urine toxicology, and cannabis use results collected at one academic site between 2012 and 2015 as part of the Human Connectome Project. The cohort (mean age, 28.7

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FDA Inspections: Lesson 1 – Interviewing Employees

FDA Law Blog

Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDAs policy position. But what exactly constitutes delaying, denying, limiting or refusing an FDA inspection?

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Prescribing Red Flags: Pharmacists Be Wary of What the Doctor Orders

FDA Law Blog

For a controlled substance prescription to be effective, that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. By Larry K. Houck Last month the U.S. 81, 86, 251.

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Episode 176: Antiracism in Medicine Series – Episode 8 – Towards Justice and Race Conscious Medicine

The Clinical Problem Solvers

Rather than searching for obscure explanations for inequalities, we must instead recognize the ways that racism impedes health at both individual and structural levels. However it is important to remember that this political invention DOES affect biology because of the way that it creates social inequity.

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Through with Breakthrough? FDA’s New Draft Guidance Reflects an Uptick in Notices of Intent to Rescind

FDA Law Blog

Breakthrough Therapy Designation (BTD) was created in 2012 as part of the FDA Safety & Innovation Act (FDASIA). For CDER specifically, the division must discuss the proposed rescission with CDER’s Medical Policy Council prior to notifying the sponsor.

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