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Empowerment Self-Defense Arms ED Staff Against Rising Workplace Violence

Physician's Weekly

Created in consultation with emergency medicine professionals, the show aims to raise awareness and provide validation to frontline healthcare workers everywhere. Created in consultation with emergency medicine professionals, the show aims to raise awareness and provide validation to frontline healthcare workers everywhere.

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Approaches for Quelling Stigma related to COVID-19

BMJ

A multilayered view of stigmatizing discourses lays the foundation for eliciting a series of suggestions for quelling stigma, to be implemented at the individual, community, and national levels, as suggested by the WHO. 2014 (28 August). Ebola-related stigma in Ghana: Individual and community level determinants.

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

FDA Law Blog

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. Premarket Approval or De Novo pathways). This comparison is misplaced.

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Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

FDA Law Blog

The Seventh Circuit took a more lenient approach than the Fourth Circuit, focusing its rationale on whether an independent contractor had improper influence over a healthcare providers independent healthcare decisions. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th

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Through with Breakthrough? FDA’s New Draft Guidance Reflects an Uptick in Notices of Intent to Rescind

FDA Law Blog

In May 2014, FDA finalized a guidance document entitled “ Expedited Programs for Serious Conditions – Drugs and Biologics ,” (the Expedited Programs Guidance) This guidance noted that a “[d]esignation may be rescinded if it no longer meets the qualifying criteria for breakthrough therapy.”

IT 52
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Critics Suggest FDA Approving Aduhelm Will Erode the “Public Trust”: What About Patients’ Trust?

FDA Law Blog

For example, we know that cancer patients have a high tolerance for toxicity when offered a chance at improved survival, a risk tolerance that would not be shared by individuals suffering from the common cold. the morbidity, oftentimes irreversible and progressive, and morality associated with their condition).

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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 1)

FDA Law Blog

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. In September 2014—nearly ten years ago!—PTE leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”).