Family Physicians of St. Joseph
SEPTEMBER 25, 2018
In 2007, Dr. Mancini joined the practice, followed by Dr. Meadows in 2012, and Dr. Gendernalik in 2015. Written by Pat Moody on Moody on the Market When it comes to healthcare, and primary care in particular, it has become increasingly difficult to remain successful as a small, independent practice. Joseph has succeeded in doing just that.
FDA Law Blog
OCTOBER 3, 2022
district court of Massachusetts by former employee and whistleblower Michael Bawduniak in April 2012 as a qui tam action. The government also suspects violative conduct if the speakers, attendees, or consultants are selected based on the volume of their past prescriptions of the company’s products or their expected future prescriptions.
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FDA Law Blog
DECEMBER 4, 2023
The government asserted additional allegations that are outside our scope. 12, 2012). “[W]hen the circumstances surrounding the presentation of a prescription would give rise to suspicion in a ‘reasonable professional,’ there is a duty to question the prescription.” On October 10th, based on ability to pay, the U.S. 21 U.S.C. §
FDA Law Blog
NOVEMBER 27, 2023
According to the government, these companies knew as early as 2012 that their dehumidifiers were defective, in that they could overheat and catch fire. The government charged these individuals with conspiracy (18 U.S.C. § What led to this conviction? It is a long story that started more than a decade ago. and Gree USA Inc.
FDA Law Blog
MAY 19, 2025
By Larry K. Houck Last month the U.S. Press Release , Walgreens Agrees To Pay Up to $350M for Illegally Filling Unlawful Opioid Prescriptions and Submitting False Claims, U.S. Attorneys Office, Northern District of Illinois, April 21, 2025.
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. By Holly N.
FDA Law Blog
JANUARY 12, 2025
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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