FDA Law Blog

DECEMBER 4, 2023

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. The government asserted additional allegations that are outside our scope. By Larry K. Zarzamora Press Release.

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Treatment Plan ER Government Patient-Centered 139

Family Physicians of St. Joseph

SEPTEMBER 25, 2018

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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Family Physician Families Family Primary Care 52

FDA Law Blog

MAY 19, 2025

Opioid prescriptions for high dosages and quantities, including prescriptions that individually or in combination, provide patients with daily dosages of greater than or equal to 300 Morphine Milligram Equivalents (MMEs). Attorneys Office, Northern District of Illinois, April 21, 2025. 81, 89, 251.

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Individual Patients Provider Medical 64

FDA Law Blog

MARCH 1, 2023

In this report, it’s stated that 62% of drug shortages reported between 2012 and 2017 were due to quality issues which is attributed in part to a lack of recognition or reward for manufacturers with mature quality management systems that focus on continuous improvement and early detection of supply chain issues.

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Management Manufacturing Supply Chain Provider 45

FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J.

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Clinic Relationship Provider IT 64

FDA Law Blog

APRIL 8, 2024

MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017. Section I.C

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Supply Chain Manufacturing Government Hospital 59

GeriPal

MARCH 2, 2023

Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? There was this big thing called the CMS National Partnership to Improve Dementia Care, started in 2012. We should be able to trust all the data that comes from our governing board.

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Patient-Centered IT Healthcare Medical 96