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Barton Associates’ Dan Bassani Named to SIA’s 2025 “40 Under 40” List

Barton Associates

Since joining Barton in 2012, Bassani has been instrumental in driving company growth and modernizing sales operations. Bassani joined Barton as an account manager and quickly distinguished himself as a high-impact leader. This recognition is well deserved.” I’m excited to continue pushing boundaries and delivering impact.”

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Fast Facts: Management of sleep apnea in children

PEMBlog

Management is based on data assessed via the apnea-hypopnea index (AHI) which is the combined average number of apneas and hypopneas that occur per hour of sleep during a polysomnography (sleep study). Shiffman; Diagnosis and Management of Childhood Obstructive Sleep Apnea Syndrome. Pediatrics September 2012; 130 (3): 576–584.

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FDA Inspections: Lesson 1 – Interviewing Employees

FDA Law Blog

Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDAs policy position. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection.

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Quiet on the Set? Forbidding FDA To Take Photographs During An Inspection Can Be Regrettable

FDA Law Blog

Management, according to the Warning Letter, “stated that the investigators were not allowed to take photographs of the equipment as part of the inspection.” Then along came the FDA Safety and Innovation Act (“FDASIA”) (our firm’s summary of the law, which was enacted in 2012, is here ). 331(f)).

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An Escape Fire for Healthcare

Noreta Family Medicine

An Escape Fire for Healthcare I recently watched a film, called “ Escape Fire: The Fight to Rescue American Healthcare, ” a 2012 documentary about how the priorities in the US healthcare system are focused on increasing revenue, instead of on goals that improve health, like preventive care.

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

FDA Law Blog

An extended release (“ER”) opioid in legitimate pain management generally accompanies an IR opioid, with patients taking the ER opioid on a set schedule and the IR opioid as needed. On October 10th, based on ability to pay, the U.S. 11, 2023 ( DOJ Press Release ). 21 U.S.C. § 829; 21 C.F.R. Holiday CVS, L.L.C. d/b/a CVS/Pharmacy, Nos.

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

FDA Law Blog

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.