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Coverage
FDA’s Center for Veterinary Medicine is looking to modernize its legal authority and spur innovation over the next several years, according to CVM Director Tracey Forfa.
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The U.S. House Oversight and Accountability Committee will question U.S. Food and Drug Administration Commissioner Robert Califf as part of an investigation into the agency’s handling of tobacco and nicotine products regulation, among other issues,…
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.
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