FDA

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.

The Future of Maine’s Food Sovereignty Movement

The Future of Maine’s Food Sovereignty Movement

The increasing popularity of municipal regulation over food production in Maine may attract federal preemption challenges.

Reforming Blood Donation in the Age of COVID-19

Reforming Blood Donation in the Age of COVID-19

The COVID-19 pandemic prompts reforms of blood donation standards for gay men.

Federal Focus Shifts to COVID-19 Treatments

Federal Focus Shifts to COVID-19 Treatments

FDA releases guidance on using blood from recovered COVID-19 patients to treat new cases.

Calls for Regulatory Approval of Edible Insects

Calls for Regulatory Approval of Edible Insects

Edible insects may become essential in the wake of the COVID-19 crisis, but FDA regulation is lacking.

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.

Obligation Alleviation During the COVID-19 Crisis

Obligation Alleviation During the COVID-19 Crisis

The most surprising regulatory dimension of the coronavirus crisis may center on the lifting of rules.

Proposal to Import Prescription Drugs Faces Criticism

Proposal to Import Prescription Drugs Faces Criticism

Critics of a proposed rule to import drugs from Canada cite safety concerns and other potential problems.

FDA Versus Our Own Stem Cells

FDA Versus Our Own Stem Cells

The federal government seeks authority over stem cell treatments but risks thwarting medical advancement.

FDA Relaxes Rules on Ventilators for COVID-19

FDA Relaxes Rules on Ventilators for COVID-19

Responding to the coronavirus outbreak, a federal agency relaxes requirements on medical device manufacturers.

Will FDA Guidance Hasten Testing for COVID-19?

Will FDA Guidance Hasten Testing for COVID-19?

In the face of a massive viral outbreak, a federal regulator issues unprecedented guidance on validating COVID-19 testing.