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 21 355  ooD ANY DRUCS
 (g) give the applicant notice of an opportunity for a hea_.i_t
 before the Secretary under subsection (d) of this section on
 question whether such application is approvab|e. If the applicaat
 elecL_ te accept the opperlunity for hearing by writ_n requ_
 within thirty days after mleh notice, such hearing shall con_neaee
 not more than ninety days after the expiration of such *.hi_y
 days unless the Secretary and the applicant otherwise agree. Aay
 such hearing shall thereafter be conducted on an expedited ba_i_
 and the Secretary's order thereon shall be issued within ni_ety
 days afar the date fixed by the _ecretary for filing final briefs.
 "subs_as_:Smt ev|_eme_ _' def_me_
 (d) If the Secretary finder after due notice to the applicant in _o
 cordance with subsection (c) of this section and giving him an op_r.
 tunity for a hearing, in accordance with said subsection, that (I) the
 investig_tians, reports of which are required to be submitted to the
 Secretary pursuant to subsection (b) cf this section, do not include ado
 equate tests by all methods reas_nab]y applicable to show whether or
 not such drug is _afe for use under the conditions prescribed, reco_
 xnended, or suggested in the proposed _abeling therc_ff; (_) the results
 of such tests show that such drui_ is unsafe for use under such ccndi.
 tions or do not show that such d_g is safe for use under such condi.
 tions; (3) the methods used in, and the facilities and controls used
 for_ the manufacture, processing, and packing of such drug are inade_
 quate to preserve its identity_ str._ngth, quality_ and purity; (4) up_
 the basis of the information submitted to him as part of the applicao
 rich, or upon the basis of any other information before him with re.
 spat to such drug, he has insufficient information to determine
 whether such drug is safe for u_ under such conditions; or (_) evalo
 .... uated on the basis of the information submitted to him as part of
 application and any other information before him with respect to sum
 druB, there is a lack of substantial evidence that the drug will lmv,
 effec_ it purports or is represented to have under the conditions of u_e
 prescribed, recommended, or suggested in the proposed labeling t_er_-
 _f; or (6) ba_d on a fair eva_uat_on of all material facts_ such kshel-
 ...... _ng is false or misleading in _ny _mr_icular; he shall issue an order
 refusing to approve the application. If, after _uch notice and opportu-
 nity for hearing° the Secre_ry finds that clauses (1) through (6) de
 _ot _pply, he shall issue an order approving the application. As used
 in this subsection and subsection (e) of this section, the term "sub-
 stan_ial evidence" means evidence consisting of adequate and we|laces-
 trolled investigations, ineludin_ e_inical investigations, by exl_r_
 qualified by scientific trainin_ and experience to evaluate the eff_o
 tiveness of the drug involved, on the b_is of which it could fairly and
 responsibly be concluded by such experts that the drug will have the
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