News

ORA to shed more responsibilities as the FDA focuses the likely-to-be renamed field organization more on inspections while revamping the agency's Human Food Program. Read more

Expanding ways to generate evidence can lead to an array of benefits for medical product development, including more diverse patient representation and the potential to expedite the availability of safe and effective therapies. As data sources outside…

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…

The U.S. Food and Drug Administration (FDA) has announced additional proposed changes to the Office of Regulatory Affairs (ORA) as part of its proposal to create a unified Human Foods Program (HFP), building on a proposal announced earlier…

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. Read more

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…