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FDA Guidance to Industry Streamlines Physician Compassionate Use Requests

FDA Guidance to Industry Streamlines Physician Compassionate Use Requests

By Jordan Paradise The Food and Drug Administration (FDA) published draft guidance for industry last week detailing a streamlined process for physician submissions of individual patient requests for compassionate use of experimental drugs undergoing active clinical trials. Entitled Individual Patient Expanded Use Access Applications: Form FDA 3926, this guidance builds on a well-established system of […]

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Monday Morning Recap: The Week (2.2.15-2.8.15) in Drug & Device Law & Policy

Filed in Monday Morning Recap by on February 9, 2015 0 Comments
Monday Morning Recap: The Week (2.2.15-2.8.15) in Drug & Device Law & Policy

Well, after two snowy Mondays in a row, we’ve got…a wintry mix today. Time for the Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think. We hope you find it helpful (and that you’ll feel free to reach out–kate.greenwood@shu.edu–if […]

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Monday Morning Recap: The Week (1.26.15-2.1.15) in Drug & Device Law & Policy

Filed in Monday Morning Recap by on February 2, 2015 0 Comments
Monday Morning Recap: The Week (1.26.15-2.1.15) in Drug & Device Law & Policy

Another snowy Monday here in Newark, another Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think. We hope you find it helpful (and that you’ll feel free to reach out–kate.greenwood@shu.edu–if there are ways we could improve it). 1. At […]

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Flu Vaccinations in the Workplace – What Health Care Employers Need to Know – Part Two

Filed in Employment Law, Public Health by on January 30, 2015 0 Comments
Flu Vaccinations in the Workplace – What Health Care Employers Need to Know – Part Two

By: Joseph C. O’Keefe, Daniel L. Saperstein, and Harry N. Hudesman Editor’s Note: You can read Part One of this post here. Precautionary Alternatives to Influenza Vaccination Employers that are not under a legal obligation to impose influenza vaccine mandates and otherwise choose not to impose them, can implement other lawful precautionary measures to protect […]

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Flu Vaccinations in the Workplace – What Health Care Employers Need to Know – Part One

Filed in Employment Law, Public Health by on January 29, 2015 0 Comments
Flu Vaccinations in the Workplace – What Health Care Employers Need to Know – Part One

By: Joseph C. O’Keefe, Daniel L. Saperstein, and Harry N. Hudesman Editor’s Note: Health Reform Watch is very pleased to welcome Joseph C. O’Keefe, Daniel L. Saperstein, and Harry N. Hudesman, attorneys at Proskauer Rose in Newark, New Jersey, to the blog today. This is Part One of their two-part post; we will feature Part […]

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