Remove 2012 Remove Government Remove IT Remove Provider
article thumbnail

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.

article thumbnail

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. The government asserted additional allegations that are outside our scope. 11, 2023 ( DOJ Press Release ).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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

FDA Law

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). By Larry K. Houck Last month the U.S. Attorneys Office, Northern District of Illinois, April 21, 2025. 81, 89, 251.

article thumbnail

News on FDA’s Quality Management Maturity Program-Maturity to Continually Improve and to not be Reactive

FDA Law

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. By Holly N.

article thumbnail

FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway.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
article thumbnail

Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia.

article thumbnail

Does the Drug Shortage White Paper Fall Short?

FDA Law

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. In Section I.A,