Drug Efficacy Study: Final Report to the Commissioner of Food and Drugs - Food and Drug Administration (1969)

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Appendix c. (to the Guidelines, DES) NATIONAL ACAD£MY OF SCIENas-HATIONAL .ESEAICH COUNCIL Dlvilion of Medical Sdenc" DRUG EFFICACY STUDY Fonn A (To be submitted in duplicate by applicant I I . HDA Nv"''--- - -- -- - - -- - 2. Dote Origi nally App,...e4- - ----- ----------- l . •• o ore o ~. •••d N .__ ______________________________________________________ _____________________ .. S. Applico•f• N••------------------------------------------------ - - --- ------ ------------- ---- - - - - Oftd A4«••~------------------------------------------~~-------- 6. Quantitative Formula 7. Do- ,.,. (lolllet•. ott.)-------------------------------- - - - -- - - - -- - - -- - - - - - - - - - - - - -- - - - -- I. lo.,.. of At~M . (Orat etc. WJrttre o new dr"9 oppllcotio• toYert dilereftt roultt of ad.,iftistrotion, MJHltOte fOtlftt thoukl bt vMd.) - - - -- - - - - -- -- - - -------- - ------------------ 10. Utt tf IJtefWtvre ,.,.,.,.w, ...,, f"rtlfttnt .. • neJvets.ft ef tM dectiw.,..11 •f 1M ct...,. for th. , . , ..., fer wt.kt. It it ofett4 fn ~ loki, tt.. ,...... ieMft, or ttrochu,.. ApJHO•imottfy S to 10 ley rtf.,tncts a rt re-qu•••ed. if ovoiloble. (Attoch 10 copiet to originol form A ( blut) ond 1 copy lo dopllcalo l'or10 A (whl,.) . ) 11 . The oppl i ce~nt It iA'Iittd, if he .o dttiftt, to tvb•it OI'IJ unpubli•"•d ftiCII«Iol thOI it ~ti nent to tilt ewolvation of tM dn,u; ~.,. the Acode•y- lttMteh Cowr.cil. This •• PPI•m•ntory Moteriol •"•"14 b• poc..ag:.-: with fotM A (whi.. , . A tlt~t'- <'OPY of this -otetloi h. ,....r.c~ . ...,. COllY it Otitit~ol Whit• copy it d"'plic.ot• 51 

NATIONAL ACADEMY OF SCIINCE$-INAnONAL IES~Ot COUNOL Dlrillon of Meclcal ScJeM. DIUG lf!IICACY STUDY Fonll • lte1111 1-6 to be completed by the FDA and aHachod to f0«11 A (blue copy I. I . HOI, - - - ·- - - - - - - - - - -2. Dot. O"eiAally A-••-'--- - - - - - - - - - - -- - - 3. b 0 OTC 0 4. ~No·---------------------------------------------- ~~·~~No·~---------------------------------------- ·-~~'----------------------------------------------------------------- ~ ~-~~~----------------------------------------- lhltlls 7-10 to be co~npleted by the Panel. ~ ~~--------------------&' ~N~~~------------------ ~ ~~~··~----------------»· ·~·~----------------------- ~ ...., - ... ~ ~., ------------------- ------------ --------- - Lh~~~S~·----------------------------------------- ~ NOA n~b·""~-------------------------------------------- 53 ,....,