FDA will more aggressively conduct active safety surveillance to identify early signs of adverse events linked to medical products. FDA will also implement new requirements under the FDA Amendments Act of 2007 related to clinical trials, pediatric drugs and devices, postmarket study commitments, and the labeling and safe use of drugs. FDA will also establish unique device identifiers to track devices, facilitate device recalls, and support inventory management during disasters and the response to terrorism events. Finally, FDA will conduct more import exams and foreign and domestic inspections of medical product manufacturers.
Modernizing FDA Science and Workforce (+$50 million)
Ad Statistics
Times Displayed: 45539
Times Visited: 1299 Ampronix, a Top Master Distributor for Sony Medical, provides Sales, Service & Exchanges for Sony Surgical Displays, Printers, & More. Rely on Us for Expert Support Tailored to Your Needs. Email info@ampronix.com or Call 949-273-8000 for Premier Pricing.
The budget amendment also proposes increases to strengthen FDA's capacity to support product safety and development in areas of emerging science such as nanotechnology, cell and gene therapies, robotics, genomics, advanced manufacturing, and the critical path initiative. FDA will also improve laboratories and other facilities that are essential to carrying out FDA's mission and invest in science training, professional development, and fellowship programs to strengthen and modernize the FDA workforce.
The program increases listed above include $65 million to modernize FDA's information technology infrastructure.
Additional information is available online at:
www.importsafety.gov
www.fda.gov
http://www.fda.gov/oc/initiatives/advance/food.html
###
FDA Fact Sheet: Investing in FDA's Transformation
RSS Feed for FDA News Releases [what's this?]
Back to HCB News
