is being presented by Robert J. Klepinski, Regulatory Attorney, Of Counsel, with Fredrikson & Byron and airs on Thursday, January 13th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Intended use. Indications for use. For years FDA has developed working definitions of these two terms, which vary from the definitions included in the regulations. Now FDA is questioning whether new definitions are needed. Previous industry use of the terms was based upon FDA's informal guidance, but if FDA doesn't know what they mean, does anyone?
In this audio conference, regulatory attorney Bob Klepinski discusses both the practical and the theoretical issues surrounding these two important terms and their use. The presentation looks at the statutory and regulatory definitions, and FDA's attempts to define them in guidance for industry. It also looks at what the future might hold, and how companies should proceed in the interim.
