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Adverse Events Regulatory Requirements

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA...more

Hogan Lovells

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

Hogan Lovells on

On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more

Franczek P.C.

This Is Not a Drill: School Districts Now Required to Create Threat Assessment Teams and Implement Threat Assessment Procedures

Franczek P.C. on

Governor Pritzker recently signed into law Public Act 101-0455 amending the School Safety Drill Act (105 ILCS 128/1) to require threat assessment procedures and the creation of threat assessment teams in school districts...more

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