1. 21 CFR §314.50 (d) (5) (vii) Revision April 1, 2004.
2. 21 CFR §314.520 Revision April 1, 2004.
3. 21 CFR 300.50 Revision April 1, 2004.
4. Federal Register: October 7, 2002 (Volume 67, Number 194).
5. Federal Register: October 1, 1997 (Volume 62, Number 190).