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 9 FOOD, DRUG, AND cosMm+xc ACT 21 § 355
 _kl_ce additional evidences and sha_l show tc the satisfaction of the
 _t t.h,st such additional evidence i8 material and that there were
 _aso_able grounds for failure to adduce such evidence i_ the proceed°
 before the Secret_xy, the court may order such addition_ evidence
 be taken before the Secretary and to be a,_duced upon the hearing
 _eh manner anti urn such terms and cc_ndRion_ as _ the _u_
 _y _eem proper° The _cretary may modify his findings as to the
 _ by reason of de additional evidence so taken, and he shall file
 _$ the court such modified findings which, if supported by substa_-
 _l ev/dence, shall be c_nclusive, and him recommendation, if any, for
 Se _t_ng aside of the original order° The judgment of the court af-
 ruing or setting aside any such order of the Secretary shall be final,
 subject to review by the Supreme Court of the United State,s upon cero
 _rar/or certificatio_ ss provided in _ection 1254 of. Title _° The
 _encement of proceedings under this subsection shall not, unless
 _fically ordered by the court to the contrary, operate _s a stay of
 the _ecretary'_ order.
 (i) The Secretary shall promulgate regulations for ezempting from
 _he operation of the foregoing subsections of _his section drug_ in+
 _e_ solel_ _or inve_ti_ationa] use by experts qualified by scientific
 t_drdng _d experience to investigate the safety and effectiveness oŁ
 _ru_. Such reguiatio_ _ay+ within the di_cre_io_ of the Secretary,
 _ong other conditions relating to the protection of the public health,
 lay/de for conditioning such exemption upon_
 (1) the submission to the Secretary, before any clinical _sting
 of & new drug is undertaken, of reports, by the manufacturer or
 the sponsor of _he investigation of such drug, of preclinical _e_ts
 (including tests on animals) of such drug _+dequate _ justify the
 proposed clinical testing;
 (2) _e manufacturer or the sponsor of the investigation o_ a
 new dru_ proposed to be distributod to investigators for clinical
 tasting obtaining s signed agreement from _sch of such investiga-
 tors that patients t_ whom the drug is administered will be under
 his per_nal _uperv_sion, or under the supervision of investigators
 responsible t_ him, _d that he will net supp|y such drug to any
 s_er investigator, or _ clinics, for administration to human
 beings; and
 .... (_) the establishment and maintenanve of such records, and the
 making of such reports _o the Secretary, by the +manufacturer or
 _e sponsor of the investigation of such druB, of data (including
 but not limited to analytical reports by investlgater_) obtained as
 _e result of such investiga_ional use of _ueh drug, as the Se_re-
 .... 391
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