Rebecca Griffith - Comment

In reference to No. 2007M-0468 Supplemental Applications Proposing Labeling Changes for Approved Drug, Biologics, and Medical Devices by the Food and Drug Administration. First, I think it is important that the FDA formally publish the activies and practices that it is already engaged in. This is important so that companies and the public understand the procedures the FDA. This will create more effeciency and ease in doing business with the FDA. When the public is aware of how an agency works, they can more easily work communicate and work with the agency. This also allows the public to feel more comfortable with the agency because its procedures are more transparent. In regards to Supplemental Applications Proposing Labeling Changes for Approved Drug, Biologics, and Medical Devices, it is important to take into consideration new research, pharmaceutical development and greater understanding that comes with time and use of medical products. It is imperative that as new research becomes available, the public is made aware of it and they can be use products more safely and with greater confidence. In addition, it is important the the FDA have oversight of amending warnings. This is a check on pharmaceutical companies that might inadvertantly misstate warnings or lessen them so the drugs seem more appealing. Therefore, the FDA should review the supplemental applications. Rebecca Griffith, University of Oklahoma College of Law - ...In reference to No. 2007M-0468 Supplemental Applications Proposing Labeling Changes for Approved Drug, Biologics, and Medical Devices by the Food and Drug Administration. First, I think it is important that the FDA formally publish the activies and practices that it is already engaged in....