FDA Urges Congress to Establish National Food Lead Testing Requirements
The agency is working to reduce children's exposure to lead and other heavy metals, according to testimony provided by FDA Administrator Califf
The agency is working to reduce children's exposure to lead and other heavy metals, according to testimony provided by FDA Administrator Califf
Further improvements to medical device quality, surveillance and the medical device recall program are planned by the FDA throughout 2024.
The FDA has announced yet another recall for HeartMate left ventricle assist systems, which have been linked to serious problems in recent years, and may have contributed to dozens of patient deaths.
The request must be assessed by the White House before being proposed for approval by the U.S. House and Senate.
The New Jersey production facility has a history or quality control problems over the last several years, according to FDA records.
Law makers question whether FDA knew the manufacturer was withholding information about Philips CPAP problems, and failed to take enforcement action to require an earlier recall.
Stakeholders are being asked to consider the risks of candy-like medications, such as child poisoning, as well as benefits that may include better patient adherence to prescribed dosing.
Critics point to the recent FDA approval of the controversial new Alzheimer's drug Aduhelm, which led some scientific advisors to step down in protest
Stakeholders told the agency that the proposed rule, first introduced in 2005, uses outdated information on food, manufacturing, and marketing technology, and that it was overly complex.
Critics say the proposed reorganization of the Human Foods Program does not go far enough to adequately protect public health.