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

Family Physicians of St. Joseph

Joseph, the family medicine practice is committed to providing exceptional, affordable, patient-centered primary care in SW Michigan without reliance on insurance companies for payment of services. John Proos, with the goal of providing exceptional care to the patients of Berrien County. Joseph has succeeded in doing just that.

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

FDA Law

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. 11, 2023 ( DOJ Press Release ). 21 U.S.C. § 829; 21 C.F.R.

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

FDA Law

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. 81, 89, 251.

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 FDA’s New Draft Guidance Reflects an Uptick in Notices of Intent to Rescind

FDA Law

Breakthrough Therapy Designation (BTD) was created in 2012 as part of the FDA Safety & Innovation Act (FDASIA). Subsequently, CDER, in MAPP 6025.6 , and CBER, in SOPP 8212 , provided more granularity as to how this process would work with step-by-step instructions for FDA staff.

IT 52
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Parvo Podcast! Erythema Infectiosum, Fifth Disease, and more!

PEMBlog

Only about 25% of infected individuals will have this classic rash syndrome. Learning Objectives Describe the classic and atypical clinical presentations of Parvovirus B19 infection in pediatric patients, including erythema infectiosum, arthropathy, transient aplastic crisis, and chronic anemia in immunocompromised hosts. But what is it?

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Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

FDA Law

The draft guidance provides recommendations for applicants and manufacturers about the requirements for notifications about production changes of certain finished drugs and biological products and certain active pharmaceutical ingredients (API), and outlines information FDA would like to receive in addition to the requirements.