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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. When announcing the transition to a Direct Primary Care practice in April, 2017, they were met with criticism, anger, misunderstanding, and the loss of many patient relationships that meant a great deal to the entire team.

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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