Marissa Fritz

Using Subjective Evidence in FDA Review

Using Subjective Evidence in FDA Review

Scholars call for greater transparency in how FDA uses subjective evidence in treatments for brain injuries.

Regulating Complaints in Human Subjects Research

Regulating Complaints in Human Subjects Research

Scholar examines the institutional review board process for resolving disputes in human subjects research.

Regulating Rationing During the COVID-19 Crisis

Regulating Rationing During the COVID-19 Crisis

Regulators and policymakers review old rules and propose new guidelines for rationing ventilators.

Encouraging Competition Through Generic Drugs

Encouraging Competition Through Generic Drugs

FDA clarifies its generic drug approval process in an effort to encourage market competition.

Resolving Regulatory Confusion Over Medical Software

Resolving Regulatory Confusion Over Medical Software

FDA clarifies enforcement priorities for medical device clinical decision support software.

Drug Approval During a Public Health Crisis

Drug Approval During a Public Health Crisis

FDA’s approval of an Ebola vaccine can serve as a framework for drug development during other epidemics.

Determining the Safety of CBD Products

Determining the Safety of CBD Products

FDA warns consumers that the agency has not evaluated most CBD products and cannot say they are safe.

Promoting Primary Care in Medicine

Promoting Primary Care in Medicine

Experts suggest changing Medicare’s payment structure to encourage physicians to pursue primary care specialties.

Human Milk Markets Need Regulation

Human Milk Markets Need Regulation

Scholar says that human milk should be regulated to ensure donor milk is safe, accessible, and affordable.

More Regulation Needed to Combat Risks From Cosmetics

More Regulation Needed to Combat Risks From Cosmetics

Scholar argues that the association between cosmetics and femininity has contributed to harmful under-regulation.

Determining How to Regulate Encapsulated Placenta

Determining How to Regulate Encapsulated Placenta

Scholar argues that FDA should use a narrowly tailored framework to regulate encapsulated placenta pills.

Invoking a Right to Try in Regenerative Medicine

Invoking a Right to Try in Regenerative Medicine

Scholars caution against using the Right to Try Act to skirt regulation for regenerative therapies.