FDA wants more funding
Device Regulation Alert: Safety, Compliance and Reimbursement News, June 30, 2008
The Department of Health and Human Services asked Congress to provide the FDA with $275 million more to fund initiatives aimed at imported drugs and medical products. The increase, if granted, would increase funding for the FDA to $404.7 million for 2009.
The FDA wants to use the extra funding to establish a presence in five other countries and conduct other activities that will monitor foreign compliance with FDA standards. The FDA would also increase both foreign and domestic inspections of food and medical product facilities and update the FDA’s information technology.
A fact sheet presents more detail about the FDA’s planned initiatives as well as past efforts. The anticipated activities affecting medical devices include:
Focus on safety of pediatric drugs and devices including reviewing safety related events and continuously evaluating and minimizing risks of products
Gather and maintain standardized data about drugs, biologics, and medical devices in a way that will increase efficiency of approvals
Click here to read a press release regarding the budget request.
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