BioCentury
ARTICLE | Politics & Policy

FDA misses deadline to submit MDUFA proposal

January 19, 2012 1:34 AM UTC

FDA said it did not submit a MDUFA reauthorization proposal to Congress by the statutory Jan. 15 deadline because the agency is still negotiating details of the plan with industry. The U.S. House Energy and Commerce Committee's health subcommittee is scheduled to hold a hearing Feb. 15 on MDUFA reauthorization. ...