Event Date/Time: Sep 30, 2008
On September 27, 2007, the President signed into law the most recent amendments and reauthorized some existing provisions in what is called the Food and Drug Administration Amendments Act (FDAAA) of 2007. The FDAAA adds many new provisions to the FD&C Act and provides important resources and adds strength to the FDA's ability and commitment to safeguard and advance public health. This presentation will give an overview of the FDAAA and summarize the new provisions pertaining to specialized pediatric medical device development, food safety, advisory committee provisions, clinical trial registries and drug safety enhancement provisions.
Areas Covered in the seminar:
* Reauthorization of existing laws.
* Reagan-Udall Foundation.
* Improved Clinical Trial Databases and Requirements.
* Clinical Trial Registry Requirements .
* FDA's new authority to address post market and surveillance issues concerning medical products.
* New food safery provisions.
* Advisory Committee provisions.
* New user fee program to support FDA review of direct to consumer advertising.
Who will benefit:
This webinar will provide valuable information to those who develop and market Medical Devices, Pharmaceuticals for both adults and children, Biologics and those engaged in the manufacture and distribution of food.
* Regulatory Affairs officials in the FDA regulated industries
* Those personnel engaed in Clinical trials and the sponsors of clinical trials
* Medical Researchers