Recent Supreme Court decisions have provided new protection to commercial speech, challenging the manner in which FDA regulates industry. In response, FDA takes great care to not mention advertising and has shifted its enforcement focus to indications.
The Food, Drug, and Cosmetic Act (FDCA) does not give FDA broad control over advertising, yet it does give FDA explicit control over the approval/clearance process and the resulting indications. FDA is tightening up on statements in ads by closely interpreting indications. This makes it even more critical to plan and write accurate PMA and 510(k) scopes to prevent FDA enforcement.
This audio conference discusses the best way to work within the new reality of FDA advertising enforcement.
Indications: The Next Battleground in FDA Advertising Enforcement was presented by Robert J. Klepinski, Fredrikson & Byron and aired on 2007-01-18. For more details, or to register please visit our site at www.fxconferences.com
