Mainstreaming Reproductive Genetic Innovation
Four potential avenues for structuring a societal discourse on reproductive genetic innovation in the U.S.
FDA
-
Read more: Mainstreaming Reproductive Genetic Innovation -
Read more: Is Preemption the Cure for Healthcare Federalism’s Restrictions on Medication Abortion? Is Preemption the Cure for Healthcare Federalism’s Restrictions on Medication Abortion?
The consequences that result from state bans and restrictions on medication abortion represent just one example of “healthcare federalism.”
-
Read more: Book Review: ‘Drugs and the FDA: Safety, Efficacy, and the Public’s Trust’ by Mikkael A. Sekeres Book Review: ‘Drugs and the FDA: Safety, Efficacy, and the Public’s Trust’ by Mikkael A. Sekeres
“Drugs and the FDA” is a must-read for anyone interested in how the FDA became the trusted regulatory agency it is today.
-
Read more: Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 3 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?
-
Read more: The Supreme Court Threatens to Undermine Vaccination Decisions Entrusted to the States The Supreme Court Threatens to Undermine Vaccination Decisions Entrusted to the States
The Supreme Court seems poised to say that the existence of a secular medical exemption to vaccine mandates means a state must offer a religious exemption.
-
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.
-
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.
-
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.
-
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?
-
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?
