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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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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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Wave of Warning Letters to Foreign OTC Drug Manufacturing Facilities Following Remote Records Requests

FDA Law Blog

Section 704(a)(4) was added to the FDCA by the Food and Drug Administration Safety and Innovation Action (FDASIA) in July 2012. Despite FDA having the authority to conduct paper inspections since the statutory provision was added to the FDCA by FDASIA in 2012, FDA did not issue a warning letter citing Section 704(a)(4) until January 2021.

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Long Time Passing: Where Have All the De Novo Decision Summaries Gone?

FDA Law Blog

The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process.

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs application and use of accelerated approval has evolved dramatically since it was first developed by the Agency to help address the HIV/AIDS epidemic in the late 1980s.

Clinic 64
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Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

FDA Law Blog

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. FDA-2022-E-3124 ).

Clinic 59
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Under Pressure: Hypertensive Emergencies in the Pediatric Emergency Department

PEMBlog

Before your blood pressure rises as well, know that this PEMBlog article is here to provide an overview of the recognition and management of hypertensive emergencies. Nicardipine dosing: bolus at 30 mcg/kg/bolus (maximum 2 mg/dose), then a continuous drip at 0.5-4 4 mcg/kg/min; onset of action is less than 5 minutes.