WASHINGTON—House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) today opened a hearing titled “Oversight of the U.S. Food and Drug Administration” to bring transparency to a pattern of issues within the U.S. Food and Drug Administration (FDA) to ensure the FDA is prioritizing safety and effectiveness and incentivizing innovation.
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.
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, according to a press release.
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, ten outcomes, and several corresponding objectives.
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 that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.
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 United States mainland and 37,000 cases in Puerto Rico and other US Territories.
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 online in 2022 as a way to knock the agency for the perception that it focused too much on things that were not its Human Foods Program, such as drugs.
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—several other biopharma companies also have drug candidates that have shown promise in clinical testing. Unfortunately, as so many families and physicians know, the road to approval of new treatments for rare diseases is long and slow.
