9/41
Category I
(= safe; effective; and not misbranded)
Classification panel 1974-1979 (601.25)
(= safe; effective; and not misbranded)
Classification panel 1974-1979 (601.25)
nConclusive evidence;
or
nAcceptable evidence,
along with
nWidespread
acceptance and use
nClinical
syndrome documented
nFavorable
in vitro changes
nSystematic
observation of possible AEs
nNatural
history understood
p. 3094