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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. Current Responses: Necessary but Insufficient Medical organizations have responded with advocacy efforts and public campaigns.

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Episode 155: Antiracism in Medicine Series – Episode 5 – Racism, Power, and Policy: Building the Antiracist Health Systems of the Future

The Clinical Problem Solvers

Understand that collective action and a focus on community, rather than individualism, are most effective in combating racism and achieving health equity. One of the biggest barriers to health equity is the narrow focus on the individual and a failure to see health as a widespread community issue.

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

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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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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Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law Blog

2014); U.S. The lowest risk category, which is not subject to any oversight by FDA, includes HCT/Ps removed from an individual that are implanted into the same individual during the “same surgical procedure.” Regenerative Sciences, LLC , 741 F.3d 3d 1314 (D.C. Stem Cell Clinic, LLC , 998 F.3d 3d 1302 (11th Cir.

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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 FDA’s New Draft Guidance Reflects an Uptick in Notices of Intent to Rescind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.”

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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

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. Walsh & Sophia R. Gaulkin & Steven J. This scrutiny was enhanced after the Fourth Circuits ruling in United States v. Mallory , 988 F.3d Polin , 194 F.3d