by pharmaceutical companies, and they have all
been developed with a lot of industry input. By
these measures, they can be judged to have been
successful.
It should be noted that regulatory practices with
FDA are constantly evolving. Pharmaceutical phy-
sicians should always check the current edition of
the 21CFR.
References
Code of Federal Regulations. 1997. Title 21, Chapter I,
various paras as mentioned above.
Federal Food, Drug and Cosmetic Act, Title 21, sections
201–901.
Fox AW. 1996. ‘The US IND: practical aspects’.Reg.
Aff. J. 7 : 371–377.414 CH32 SPECIAL US REGULATORY PROCEDURES