Food and drug administration involvement and approval

✍ Scribed by David H. Woodbury

• Book ID: 104375634
• Publisher: Springer
• Year: 1995
• Tongue: English
• Weight: 428 KB
• Volume: 2
• Category: Article
• ISSN: 1071-3581
• DOI: 10.1016/s1071-3581(05)80009-1

✦ Synopsis

The birth

MINISYMPOSIUM of a new radiopharmaceutical

Several new radiopharmaceuticals for myocardial perfusion imaging have been approved for clinical use in recent years or are presently undergoing clinical testing. The time, effort, and cost involved in the entire process of development of a radiopharmaceutical, from initial conception to final approval for clinical use, is enormous. The following series of articles, which use 99mTc-labeled sestamibi as an example, is meant to clarify and to provide better insight into the various stages of the entire process of development and approval.

The perspective of the Food and Drug Administration (FDA) on the development of a new radiopharmaceutical is given by