"Guidance for Industry and Reviewers: Exploratory Investigational New Drugs (EIND) Studies" protects patients while simultaneously providing a pathway to investigators for conducting life-saving studies more efficiently than ever before. "Guidance for Industry: Approaches to Complying With Current Good Manufacturing Practice (CGMP) During Phase 1 Studies" will facilitate the production of investigational drugs for use in phase 1 studies, with the primary focus again on human safety.
"These guidance documents took a significant amount of the FDA's time and dedication to ensure a secure process for researchers and developers of drugs and biological products," said SNM President Peter S. Conti, M.D., Ph.D., professor of radiology, clinical pharmacy and biomedical engineering at the University of Southern California, Los Angeles. "The nuclear medicine and molecular imaging community appreciates their hard work," added Conti, who as SNM president represents more than 16,000 physician, technologist and scientist members.
"FDA staff has truly gone to great lengths to respond to the feedback from the medical and scientific communities regarding the EIND studies guidance and have incorporated many of the suggestions into these final documents," said Henry F. VanBrocklin, Ph.D., who led the SNM task force that compiled and submitted comments on EIND when the draft version was released to the public in spring 2005. "Patients will undoubtedly benefit from the resulting increase in the number of new imaging agents that will become available through the EIND process. These agents will not only directly benefit the public in the form of new diagnostics, but, in partnership with pharmaceutical companies, will also enable the development of new drugs," added VanBrocklin, professor of radiology at the University of California, San Francisco.
"Guidance for Industry and Reviewers: Exploratory IND Studies" can be accessed through the FDA's Web site at http://www.fda.gov. "Guidance for Industry: Approaches to Complying With Current Good Manufacturing Practice (CGMP) During Phase 1 Studies"--expected to replace the 1991 document, "Guidance on the Preparation of Investigational New Drug Products (Human and Animal)"--is currently available for public comment.
About the Society of Nuclear Medicine
The Society of Nuclear Medicine is an international scientific and professional organization of more than 16,000 members dedicated to promoting the science, technology and practical applications of nuclear medicine and molecular imaging to diagnose, manage and treat diseases in women, men and children. Founded more than 50 years ago, SNM continues to train physicians, technologists, scientists, physicists, chemists and radiopharmacists in state-of-the-art imaging procedures and advances; provide essential resources for health care practitioners and patients; publish the most prominent peer-reviewed resource in the field of nuclear and molecular imaging: The Journal of Nuclear Medicine; sponsor research grants, fellowships and awards; and host the premier nuclear medicine annual meeting. SNM members have introduced--and continue to explore--biological and technological innovations in medicine that noninvasively investigate the molecular basis of diseases, benefiting countless generations of patients. SNM is based in Reston, Va.; additional information can be found online at http://www.snm.org.