Events
Duane Morris Special Counsel Michael Swit to Provide a "Legal and Regulatory Update— Health Care Reform and FDA Developments "
November 13, 2012 | San Diego
| BIOCOM Boardroom
Duane Morris special counsel Michael Swit will discuss "FDA Developments " as part of the BIOCOM Reimbursement and Market Access Series on Tuesday, November 13, 2012, in San Diego.
As a new presidential administration begins, regardless of who occupies the White House, the 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. In this part of the program, speakers will explore not only the impact of FDASIA, but also other key FDA initiatives impacting the local life sciences community. And, with the session occurring a week after Election Day, we also will explore the potential impact of the election results on FDA's operations in the coming year.
For additional information, or to register, please visit the BIOCOM website.
