Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 3
Once sponsors decide to capture/share expanded access-derived data above and beyond that needed, what should IRBs do?
FDA
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Read more: Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 3 -
Read more: Book Talk: Choose Your Medicine: Freedom of Therapeutic Choice in America Book Talk: Choose Your Medicine: Freedom of Therapeutic Choice in America
RecordingEvent Description On November 3rd, we hosted a book talk and moderated discussion with author Lewis A. Grossman on his new book, Choose Your Medicine: Freedom of Therapeutic Choice in America, and respondent William M. Sage, Professor of Law and Medicine at Texas A&M University. In Choose Your Medicine, Grossman explores the history and impacts…
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Read more: Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 2 Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 2
In some cases there may be value in collecting “real world data” from Expanded Access.
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
Interesting empirical studies, policy analyses, and editorials on health law and policy issues from August 2022.
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Read more: Get Your Story Straight: Patent Office Cracks Down on Inconsistent Statements Made Before the FDA Get Your Story Straight: Patent Office Cracks Down on Inconsistent Statements Made Before the FDA
While it may not seem controversial to promote honesty before the USPTO, a recent Federal Register Notice goes far beyond requiring candor.
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Read more: Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 1 Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 1
Expanded access allows patients who lack other treatment options to try unapproved medical products in development.
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Read more: FDA and Emergency Response FDA and Emergency Response
RecordingLearn more about the FDA’s emergency response to issues such as COVID-19, monkeypox, and infant formula. On September 20th, we hosted a discussion of these topics and more with FDA Principal Deputy Chief Counsel Mark Raza in conversation with PFC Faculty Director, I. Glenn Cohen. Panelists This event was sponsored by the Petrie-Flom Center for Health Law…
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Read more: Can Children Consent to the COVID Vaccine? The Case of Foster Care and Juvenile Justice Can Children Consent to the COVID Vaccine? The Case of Foster Care and Juvenile Justice
Can young people consent to COVID-19 vaccinations?
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
Interesting empirical studies, policy analyses, and editorials on health law and policy issues from July 2022.
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Read more: Mushroom Monographs? The FDA’s Potential Role in a Legal Recreational Drug Market Mushroom Monographs? The FDA’s Potential Role in a Legal Recreational Drug Market
How should the FDA regulate recreational drugs, if it has the power to do so?