Fall 2010 issue

Biotechnology Healthcare
“Oncology Biomarker Diagnostics: Where We Are, Where We Need To Be”

This wide-ranging article examines the reasons behind the relatively low number of commercialized diagnostic products in oncology. Catalyst President Nancy Bradish Myers comments on the potential impact of an upcoming guidance from FDA’s Center for Devices and Radiological Health. She also comments on FDA’s review of its 510(k) device approval process.

Catalyst President and Alliance for a Stronger FDA Vice President Nancy Bradish Myers comments on FDA funding under the new Continuing Resolution
Click below to view the Alliance for a Stronger FDA press release, issued September 30, 2010:
“Alliance Commits to More FDA Funding In Continuing Resolution”

The Alliance for a Stronger FDA expresses concern that the new FY 2011 Continuing Resolution (CR) provides no additional funding for the FDA. The CR funds the federal government through December 3, 2010. The group will urge Congress to increase funding when it considers the next CR after Election Day.

“For FDA, this could mean a slowing of its efforts to provide for adequate food inspectors and reviewers looking at the safety and efficacy of innovative medical products,” said Nancy Myers, Vice President of the Alliance. “The headlines over the last several months, such as the massive recall of contaminated eggs, make clear we need to continue to support improved funding levels for the agency.”

She added: “If the agency is put in a situation that it cannot adequately meet modern day regulatory challenges in a timely manner, it may have both health consequences and cause unnecessary job losses here in the US.”

2017-11-19T18:56:32+00:00