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

FDA Law Blog

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. By Larry K. On October 10th, based on ability to pay, the U.S. Zarzamora Press Release. Holiday CVS, L.L.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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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, P.C.,

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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. 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 FDA’s New Draft Guidance Reflects an Uptick in Notices of Intent to Rescind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 Blog

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Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Since the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, manufacturers have been required to notify FDA of product changes affecting certain finished drugs and biological products.

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Critics Suggest FDA Approving Aduhelm Will Erode the “Public Trust”: What About Patients’ Trust?

FDA Law Blog

In 2012 we at the Agency, under Dr. Janet Woodcock’s leadership, identified the need for more systematic patient engagement — a way to improve representativeness and be more proactive rather than reactive to interacting with patient communities. However, the scope of patient input goes beyond setting the clinical context.