Events
Duane Morris Special Counsel Michael Swit to Speak on "FDA Update: Impact of FDASIA and the Federal Elections"
November 15, 2012 | San Diego
| CareFusion Corporation
Duane Morris special counsel Michael Swit will be speak on FDA Update: Impact of FDASIA and the Federal Elections" on Thursday, November 15, 2012 on behalf of the San Diego Regulatory Affairs Network (SDRAN).
The SDRAN program will begin at 5:30 p.m. with registration and networking, followed by Mr. Swit's presentation from 6:00 p.m. to 7:00 p.m.
As we enter a new presidential administration, regardless of who occupies the White House, FDA will be implementing a number of new measures as a result of the enactment in July 2012 of the Food and Drug Administration Safety and Innovation Act (FDASIA). FDASIA not only reauthorized the various User Fee acts that are essential to financing the review process in the FDA centers that govern life sciences companies, but also instituted a number of important new statutory measures for pharmaceutical, biotech, medical device and diagnostic companies regulated by the FDA. The agency's new powers range from implementing new incentives to develop therapies for antibiotic-resistant infections to mandating a unique device identifier (UDI) system to enhanced inspection authority.
For more information, or to register, please visit the SDRAN website.
