Guidance

Promoting Consistency and Transparency in Individualized Guidance

Promoting Consistency and Transparency in Individualized Guidance

New research highlights the unique challenges agencies face when providing individual regulatory guidance.

Agency General Counsels, Beware

Agency General Counsels, Beware

Federal agencies can face legal risk if they only provide constructive notice of regulatory changes through publication and FOIA “availability.”

Making Inoperative Guidance Accessible to All

Making Inoperative Guidance Accessible to All

Even when agencies change or rescind guidance documents, they should be clearly labeled and readily available to the public.

Ending the Long Wait for Federal Guidance on Reopening Schools

Ending the Long Wait for Federal Guidance on Reopening Schools

The Education Department’s COVID-19 guidance may signal a return to information sharing.

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.

The Trump Administration’s New Title IX Rule

The Trump Administration’s New Title IX Rule

A new rule brings changes to enforcement of sexual harassment regulations in higher education.

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.

Florida’s Unemployment Insurance System Breaks Down Under COVID-19

Florida’s Unemployment Insurance System Breaks Down Under COVID-19

Unemployed Floridians could lose weeks’ worth of jobless benefits they would otherwise be due.

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.

Incomprehensibility and the Law

Incomprehensibility and the Law

The law needs not only to correct information asymmetries but comprehension asymmetries too.

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.

Resolving Regulatory Confusion Over Medical Software

Resolving Regulatory Confusion Over Medical Software

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