norml08 - Page 30
Page 30
Previous ,
Next ,
Original Image
Return to Index
...
drug combined with other drugs are irrelevant. United
States v. Articles of DrUq oo.Pr_pmise Tooth as_, 826 Fo2d
564, 570 (7th Ciro 1987) o Incomplete studies are
insufficient. United States vo Articles of Food & D_dq,
suDr_. Uncontrolled studies are ins1_fficiento 21 U_S.C.
355(d); C Q_qper Labs v. FDA, 501 F_2d 772_ 778 (D.C. Cir.
1974). Statistically insignificant studies are
insufficient. 21 CFR 312.21, 3i4 ° 50 [d) (6) and
314o126(b) (7). Poorly designed studies are insufficient.
21 CFR 314o126(b) (2). Poorly conducted studies are
insufficient. 21 CFR Part 58 - Good Laboratory Practices.
Poorly documented studies are insufficient° 21 CFR 312.58
and 314.200(e) (4). Studies by investigators who are not
qualified, both to conduct and to evaluate them_ are
insufficient° 21 U.S.C° 355(d). Moreover_ since scientific
reliability requires a double examination with similar
results, one valid study is insufficient. There must be two
or more valid studies which corroborate each other. See
1 Jo O'Reiliey "Food and Drug Administration" i3-55 n.12
(1985) o
Lay testimonials_ impressions of physicians_ isolated
case studies, random clinical experiences reports so lacking
in details they cannot be scientifically evaluated, and all
other forms of anecdotal proof are entirely irrelevant.
21 CFR 314o126(e}; Weinber_er v. H_pqD____Etc_ , 412 U.S. 609,
/............. 630 (1973) o
3O
Previous ,
Next ,
Return to Index