News

On December 18, 2023, Dr. Brian King, the Director of FDA’s Center for Tobacco Products announced the Center’s new five-year strategic plan which outlines the Center’s programmatic and workforce initiatives and includes five goals,…

Today, the FDA is releasing several scientific review policy memoranda that provide a snapshot of the FDA's internal thinking on certain topics within the premarket tobacco review process.

US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting…

In 2015, the United States Food and Drug Administration (US FDA) and other Department of Health and Human Services agencies helped respond to a public health emergency concerning Zika Virus during which 5,600 cases of the virus were reported in the…

Every organization goes through ups and downs. And the Food and Drug Administration is no different. But the stakes are higher when you’re tasked with protecting public health. So, it’s understandable when “Put the F Back in FDA” started trending…

When the U.S. Food and Drug Administration made the opioid overdose reversal drug naloxone an over-the-counter medication last summer, health care advocates praised the removal of the prescription barrier as an effective tool to prevent fentanyl deaths…

At Denali Therapeutics, where I serve as chief medical officer and head of development, we are eager to develop new treatments for progressive and debilitating neuronopathic mucopolysaccharidoses diseases with our novel technology. We are not alone…

A meeting convened by the Reagan-Udall Foundation for the FDA on qualifying rare disease biomarkers for accelerated approvals could be an inflection point for patients with ultrarare diseases, their families, biotech companies, and FDA. Read…

The FDA will increasingly use accelerated approval for gene therapies aimed at rare conditions, according to Peter Marks, the FDA’s top official overseeing cell and gene therapies, the clearest signal yet of how widely the agency will deploy its…

On February 21, the Biotechnology Innovation Organization’s (BIO) soon-to-be CEO, John F. Crowley, joined an event about biomarkers and rare disease regulatory pathways, hosted by the Reagan-Udall Foundation for the Food and Drug Administration in…