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Empowerment Self-Defense Arms ED Staff Against Rising Workplace Violence

Physician's Weekly

For physicians, nurses, medical assistants, and support staff, workplace violence (WPV) is now a daily hazard, inflicting physical injury, emotional trauma, and eroding the quality of patient care. Violence in hospital emergency departments (EDs) has reached crisis levels. The severity of this problem has even made its way into pop culture.

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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

In fact, stakeholders have repeatedly challenged FDA’s assertions of authority in Citizen Petitions, public comments, and other forums. Premarket Approval or De Novo pathways).

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. However, the 2014 Guidance cannot be ignored entirely.

Clinic 64
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Approaches for Quelling Stigma related to COVID-19

BMJ

quarantine-breakers”) or video clips of people shouting at or even physically assaulting Wuhanese or people who visited Wuhan after the outbreak. 2014 (28 August). The content of many social media posts in China have stigmatized Wuhan or Wuhanese, for example posts engaging in name-calling (e.g., doi:10.3389/fcomm.2020.00039

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Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

FDA Law Blog

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. FDA-2022-E-3124 ).

Clinic 59
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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. Policies and Procedures.

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. Policies and Procedures.