is being presented by Dr. Edward E. Berger, Principal and Founder, with Larchmont Strategic Advisors and airs on Tuesday, April 12th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Efforts to improve communications and coordination between FDA and CMS, including an initiative to implement a formal program for parallel review of new products by the two agencies, have sparked industry concern over the potential blurring of the heretofore bright line between the FDA’s market clearance function and CMS’ responsibility for Medicare coverage and payment determinations. This concern is compounded by the absence of established mechanisms at CMS for the safeguarding of company confidential information contained in regulatory submissions.
This audio conference presentation looks at the present status and likely outcomes of FDA/CMS interagency coordination efforts, and evaluates the opportunities as well as the threats posed by those efforts to developers of new therapeutics, devices and diagnostics.
