May 27, 2011
The US House of Representatives’ Appropriations Committee has issued a 2012 spending bill cutting the Food and Drug Administration’s budget by $285 million, or 11.5%.
According to The Hill and MassDevice.com, such cuts could significantly impact the agency’s plans for implementing more robust 510(k) clearance processes, as well as affect reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA) next year.
If enacted, the budget cut could also prompt the FDA to raise fees it charges to medical device and pharmaceutical firms for reviews and product approvals.
The spending bill’s passage remains far from certain, however; it must win approval by the whole House and then survive the Democratic Senate and avoid a presidential veto.
Business-friendly US lawmakers and the FDA’s Center for Devices and Radiological Health director Dr.
FDA regulations dictating informed consent requirements for drug and medical device clinical trials are set to change on March 7, 2012.
The US Food and Drug Administration (FDA) has floated the possibility of reorganizing the Center for Devices and Radiological Health (CDRH) and providing more resources to the branch in order to ad
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) would see an appropriation of $329 million—a 4.8% increase over current levels—in the Obama administration’s proposed 2012 budget. Total CDRH funding would total $395 million, with $66 million from industry user fees, if the administration has its druthers, according to The Gray Sheet .