Experts told our Robert King at POLITICO’s Next Generation of Health Care Therapies event Thursday that they’re excited about the potential for artificial intelligence to help develop and test gene therapies to treat rare diseases.
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) will hold a virtual listening session on Aug. 22 to give the public an opportunity to comment on its five-year plan it developed to advance its mission.
The U.S. Food and Drug Administration (FDA) recently provided an update on its proposal to create a unified Human Foods Program (HFP). This reorganization includes a new model for the Office of Regulatory Affairs (ORA).
The administration summarized its progress and next steps following the evaluation from the expert panel regarding the FDA's tobacco program.
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:
