FDA and PET radiopharmaceuticals

["Dale E. Boyce" <dale@radpro.uchicago.edu>]

The Feb 27 Federal Register serves notice that the FDA is reversing
their old policy regarding PET radiopharmaceuticals.  Anyone
using such materials under the practice of medicine or pharmacy
laws of their state better take a look.  A short synopsis is that
ANY use of the material for diagnosis that is not for purely
physiological research must be covered by an IND or NDA.  Research
use can still be performed under the auspices of a Pett Review Committee
registered with the  FDA ala the RDRC for Part 361.1.  No use in
humans is permitted under state pharmacy or practice of medicine.
The final kicker is that it appears that Good Manufacturing Practices
must be met for either clinical or research use.

A workshop is being held in Rockville Md. on March 21.  Registration is
required by March 7.