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

Previous , Next , Return to Index