Category Archives: FDA

Food and Drug Administration Safety and Innovation Act highlighted

Members of Delaware’s medical, pharma, and legislative communities gathered at the Helen F. Graham Cancer Center in Christiana Care Health System to discuss the U.S. Food and Drug Administration Safety and Innovation Act of 2012.

PDUFA Conf resized 600

The bill enables the FDA to collect fees from pharma companies to offset costs of regulatory reviews of biological products and drugs. The measure reauthorizes the Prescription Drug User Fee Act and Medical Device User Fee Act.

U.S. Senator Tom Carper issued the following statement:

“This bill helps ensure that Americans get access to the life-saving medications and medical devices that are developed in this country – including Delaware – as soon and as safely as possible,” said Sen. Tom Carper. “It improves the Food and Drug Administration’s ability to review and regulate drugs and medical devices for adults and children. This legislation also helps to protect patients’ access to critical medicines by creating new programs to incentivize the development of new antibiotics and reduce drug shortages. Patients, health care providers, and the pharmaceutical and medical device industries will all benefit from a more responsive and effective Food and Drug Administration– a win-win for Delaware consumers and businesses.”

and, our camera’s were there to capture the conference: