Biologics
Study Regulatory Actions
All letters issued by FDA's Center for Biologics Evaluation and Research during 2005 involved medical devices, [except Hostoffer, which was a drug] and are flagged as "CBER Warning Letter" in the device case list.
Dr. Lein 10-12-2006
Warning Letter
In view of the falsifications, I am surprised that only
a Warning Letter was issued.
Dr. Hohmann
7-10-2006 Warning Letter
After she had dosed the last subject with the
investigational vaccine, she sought FDA guidance concerning the
need for an IND. An FDA representative told her that she needed
an IND to conduct the study. Nevertheless, she failed to submit
an IND to FDA, and continued to follow the subjects through
August 2004 when she informed the IRB that the study was closed.
Envita Natural Medical Centers
of America
6-14-2006 Warning Letter
Biological products and drug products may be distributed
for clinical use in humans only if the sponsor has an
investigational new drug (IND) application in effect Your treated
cell cultures are not the subject of an approved BLA or NDA, and
you do not have an IND in effect.