This chapter is intended to assist the clinical investigator in developing products, with an emphasis on biological cellular and gene therapy products, due to their complexity, that may be used for cancer therapeutics. It is not intended as a guide for general product development or general clinical trial design and analysis nor as a guide to protective vaccine development, drugs, or devices ex...

i D HE ACADEMY of Molecular Imaging (AMI) was started in 2001 when the leadership of he Institute for Clinical PET (ICP) decided that here needed to be an organization to not only oster the clinical applications of positron emission omography (PET) but also to include the discilines and technologies of molecular imaging.1,2 efore 2001, the ICP had focused its efforts on ducation and reimburseme...

This is a very colorful paper that makes for interesting reading. The author shows that the U. S. Food and Drug Administration (FDA) increasingly does not decide about market access to drugs only, but influences the innovation process as a whole. And although "information" does not appear in the title of the paper, the distribution of knowledge as affected by the FDA plays an important role at ...

To meet its public mandate, the US Food and Drug Administration (FDA) collected studies on the potential health hazards of eating or drinking cloned food products. Based on an earlier National Academy of Sciences study that, on closer analysis, was not nearly as sanguine, the FDA's report found no evidence of a health risk from the public's ingestion of cloned food products. This article analyz...

The authors found that two-thirds of drugs approved by the FDA in recent years lacked adequate efficacy and safety information for use in older patients. With an expected doubling of the elderly population by 2040, it is time for pharmaceutical manufacturers to incorporate more robust prescribing information into their product labels of drugs used in this patient population.