FDA

Earlier this year, the United States Food and Drug Administration (FDA) published a proposed rule that would amend its “intended…

The FDA issued a draft guidance regarding its postmarketing requirements (PMRs) and commitments. The document details how drug and…

A new temporary guidance for drug and biologics manufacturers from the U.S. Food and Drug Administration (FDA) details…

Earlier this year, the Trump Administration released a final rule focused on allowing states and others to establish programs to…

On August 11, 2020, the United States Food and Drug Administration (FDA) held a public meeting to discuss a report that reviewed…

In late September 2020, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) released a…

On August 31, 2020, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued the…

This year has been a very slow year for enforcement letters from the United States Food and Drug Administration (FDA) Office of…

Recently, the United States Food and Drug Administration (FDA) issued a policy guidance outlining the agency’s enforcement of drug…

We have previously written about the downward slope of enforcement letters from the United States Food and Drug Administration…