vol1 - Page 20

Page 20 Previous , Next , Original Image
Return to Index

 21 § 355 FOOD AND D UOS
 _ry finds will enable him to evalua_ the safety and effectivene_
 of such drug in the event of the filing of an a_plication _ursu_t
 to subsection (b) of this section°
 _uch regulations shall provide that such exemption shall he teRM.
 tioned upon the manufacturers or the sponsor of the inves_gatio_ _,_
 qui_ng _hat experts using such drugs for investi_ational PU_oses
 certify to such manufacturer or sponsor that _hey vr_ll infor_ a_
 human beings to whom such drugs, or any controls used in co_nee_
 tion therewith, are being administered, or their represents_Sves, that
 such drugs are being used for investigational purposes and will _h_
 tain the consent of such human beings or their representatives, e_
 cept where they deem it not feasible or, in their professional _ud_.
 men_ contrary to the best interests of such hi, man beings. Nothinf
 in this subsection shall be construed to require an)' clinical investi_
 gator to submit directly to the Secretary reports on the investi_o
 tional use of drugs.
 (j) (1) In the case of any drug for which an approval of an app,.
 cation filed pursuant to this section is in effect, the applicant shall
 tab_ish and maintain such records, and make such reports to the _r_
 tsry, of data relating to clinical experience and other _at_ or _nformao
 tion_ received or otherwise obtained by such applicant with respect t_
 such drug, as the Secretary may by general regulation, or by order
 with respect to such application, prescribe oR the blain of a findi_
 that such r_ords and reports are necessary in order t_ enable the Sec-
 retary to determine, or facilitate a determination, whether there is or
 may be ground for invoking subsection (e) of this section: Prev˘_,
 however, That regulations and orders i_ued under this subsection _2_d
 under subsection (i) of this section shall have due reg,_rd for the pro
 fessio_al ethics of the medical profession and the interests of patie_
 and shall provide, where the Secretary deems it to be _tppropriate0 for
 the examination, upon reqaest_ by the persons to whom such regula_
 tions or orders are applicab|e, of similar information received or oth-
 erwise obtained by the Secretary,
 (2) Every person required under this section to maintain record,
 and every person _n charge or custody thereof, shall, upon request of
 an officer or employee designated by the Secretary° permit such offi-
 cer or employee at all reasonable times to have _ccess to and copy and
 verify such records.
 June 2_, 193_, c. 675, § _05, 52 Star. 1052; 1940 R_rg.P_an No. IV, |
 12, elf. June 30, 1940, _ F.R. 242_, S4 Stato 12_7; June _, 1948, c.
 646, _ 32(b)_ 62 Star. 991; _ay _4_ 1949, Co 139, § I_7, 63 Stato 107;
 195_ Reorg.Plan No. L ] 5, eft. Apr. 11, 1953, 18 !P.Ro 20_3, _7 Stir.

Previous , Next , Return to Index