The dietary supplement industry is expressing concern over a proposed update to a Food and Drug Administration (FDA) reorganization that would relocate the current Office of Dietary Supplement Programs (ODSP) to a new office under its “Risk Management Functions”.
Welcome to another episode of our podcast series, “Q&A with FDA”, from the FDA’s Division of Drug Information, where we answer some of the most frequently asked questions that we’ve received. In a previous episode, we discussed FDA’s Overdose Prevention Framework with Dr.
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.
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 of traditional clinical trials become more accessible and methods for analyzing such sources become more robust, there are further opportunities to use real-world data (RWD) to evaluate safety and support evidence of effectiveness.
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, released the following statement today in response to the update:
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 this year.
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 recommendations outlined in the evaluation panel’s report.
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 revealed in two high-profile reviews of the agency.
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.
