Coverage

The Food and Drug Administration has provided an update on its proposal to create a unified Human Foods Program, which includes a new model for the Office of Regulatory Affairs. Scott Melville, president of the Consumer Healthcare Products Association…
Brian King, director of U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), published a statement summarizing the CTP’s progress in addressing the recommendations from the Reagan-Udall evaluation.
In February, I announced the Center for Tobacco Product’s (CTP) “all-center” approach to responding to the evaluation of our center by an independent expert panel facilitated by the Reagan-Udall Foundation (RUF), including our plans to address the 15…
Heeding the advice of food industry leaders and public safety advocates, FDA has “significantly broadened” the proposed responsibilities and oversight of the planned Human Foods Program under a larger reorganization that seeks to address shortcomings…
Large language models popularized by ChatGPT show up in nearly all of FDA Commissioner Robert Califf’s speeches lately, as he makes clear he wants to get ahead of regulating the disruptive technology. Read more
An appropriations bill from a committee in the U.S. House of Representatives would direct the FDA to unify its food program under one person. The move echoes the sentiment from a House committee, former FDA leaders, and experts in the field of food…
It seemed an excellent test case for a new system. After role-playing a U.S. Food and Drug Administration Tobacco Products Scientific Advisory Committee (TPSAC) member, listening to Altria’s presenters rehearse their pitch, that was my impression. Read…
Commissioner Robert Califf continues to raise attention about what he terms the “revolving door for lawyers,” between the FDA and industry. Agency staff leaving for jobs in the private sector is nothing new, but Califf mentioned during a speech at the…
U.S. Food and Drug Administration Commissioner Robert Califf has lamented the FDA’s ongoing tobacco industry litigation following the agency’s attempt to regulate e-cigarettes, according to Politico. The FDA is facing over 40 lawsuits from companies…