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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

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. Providers should be aware of the other drugs prescribed to their patients. 11, 2023 ( DOJ Press Release ).

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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.

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Parvo Podcast! Erythema Infectiosum, Fifth Disease, and more!

PEMBlog

Youll also learn how to manage exposures in the emergency department, especially when the child has a pregnant caregiver, and why isolation isnt always necessary once the rash shows up. Well break down the virology, epidemiology, clinical presentation, and complications of Parvovirus B19. So as you can see, this virus does a lot of stuff.

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Does transitional care management improve outcomes after discharge from the hospital?

Common Sense Family Doctor

Since the turn of the century, the rise of hospitalists and the corresponding decline in the number of office-based family physicians who provide inpatient care for their own patients has magnified the value of optimizing the handoff from hospital-based teams to primary care physicians.

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Under Pressure: Hypertensive Emergencies in the Pediatric Emergency Department

PEMBlog

Before your blood pressure rises as well, know that this PEMBlog article is here to provide an overview of the recognition and management of hypertensive emergencies. Management of Hypertensive Crises in Children: A Review of the Recent Literature. 4 mcg/kg/min; onset of action is less than 5 minutes.