norml09 - Page 30
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drug combined with other drugs are irrelevant. United
States Vo Articles of D u ...Promi_ Tooth aste s 826 F.2d
564; 570 (7th Cir. 1987)o Incomplete studies are
insufficient. United States v° A__f Food & Dr_e
supra. Uncontrolled studies are insufficient. 21 U.S.Co
355(d); _q99_per Labs v. FDA, 501 E.2d 772p 778 (D.C. Cir.
1974). Statistically insignificant studies are
insufficient. 21 CFR 312.21, 314o50(d) (6) and
314o126(b) (7). Poorly designed studies are insufficient.
21 CFR 314.126(b) (2) o Poorly conducted studies are
insufficient° 21 CFR Part 58 - Good Laboratory Practices.
Poorly documented studies are insufficient° 21 CFR 312.58
and 314o200(e) (4)° Studies by investigators who are not
_aalified, 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 J. O_Reilley '_Food and Drug Administration '_ 13-55 n.12
(1985).
Lay testimonials_ impressions of physicians, isolated
case studies, random clinical experience, reports so lacking
in details they cannot be scientifically evaluated_ and all
other forms of anecdotal proof are entirely irrelevant.
21 CFR 314.126(e); Weinbe_er v. H_ns_on Etc., 412 U.S. 609,
630 (1973) o
3O
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