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 FOUr AND VR_GS 21 § 355
 re_rts of _ew ctLnica] _nvestig_tio_ (other than bioavailability studies) essential
 the approva| of the supplement and conducted or ai_nsored by the person
 submitting the supp|emen_ the Secretary may not m_ke the approval of an
 applicat/on submitted under subeection (b) of this section for a change approved
 in the supp|ement effective before the expiration of three years f_rn the date of
 the approve| of the supplement under subsection _) of this section ff the
 _vest_gatio_s described _ _au_ (A) of subsection (b_l) of this section _nd
 reli_l upon by the appiica_ for approvaJ of _e app_ic_t_ were not conducted
 by or for the applicant and if the applicant has not _mined a r_gh_ of reference
 or u_ from the person by or for whom the inves_ga_ons wen conducted.
 (vt If an applic_on (or supplement ts an applic_on) submitted under _uhse¢_
 tion _ of thin s_ for a &'ug, which inc|udes an act_w ingredient (including
 •ny ester or _|t of the active ingred_nt_ that has bees approved in another
 app_cation under subsection (b) of this sectiou0 was approved duzi_g the period
 beginning J_nu_xy L 1982, _sd ending on September 2_, 19_4, the Secretary
 may uot make the approval of _ _pplic_t_on submitted under this subsec_on
 _u_d for which the inves_gations described in clause (A) of subsection _I) of
 this _tion and _|ied upon by the applicant for approval ,_f the application wen
 not conducted by or for the applicant and for which the app|icant has not
 obt_ned s right of reference or u_e from the person by or for whom the
 huvestigRt_ons were conductod and which refers to the drug for which the
 subs_on (b) applic_o_ w_ submit_d _ffec_ve before the expiration of two
 years from S_p_r_ber 24, 1984.
 (_) Grounds for r_f_stn_ s_pli_tlon; a_r@_l @f _pltc_lo_: _subs_n_ #vide_c_ _' d_
 _f the Secretary finds, _f_r due notic_ _ the app|ic_n': in accordance with
 subsection (c) of th_ a_c_on and giving him an opportunity for a hearing° i_
 accordance with said. _ubsect_or|, that (D the inves_g_t_uns, reports of which
 required te be submRted _ the Secre_ry pureuant to subsec_on (b) of this section,
 do not include adequate t_st_ by all methods reasonably applicable _ show whether
 or sot _uch drug is safe for use under the conditions pres¢_dbed, recommended, or
 . suggested _ the proposed L_b_|ing there_f_ (2) the results of such tests show that
 such chug is unsafe for u_ _der such conditions or do not s_.ow that such drug is
 _fe for use under such conditions; (3) the methods used _, '._ud the fat|limes and
 con't.rola used for, the manufacture, processing, and packing of _uch drug are
 inadequate to pzx,scr_e its iden_ty, stze_iV,.h, quality, and purity; (4_ u_u the ba_i_
 of _e infoz_atisn submitted to him gg part cf the app_iecstion, or upon the b_is of
 _ny user _uforrns_o_ before him with _espect to such drug, he hag _sufficie_.t
 _formation to determine whether such drug is s_.fe for use under such conditions;
 :_- or (5) evaluated on the b_i_ of the informa_on subrnR_.d to him ss pars of the
 spplic_o_ _ud any other informa_on before him with respect t_ such ¢h_ug, there
 a _ of subs_nt_al evidence that the drug will have the eff_c'_ _. purports or is
 repre_nted to have under the condi_o_s of use presc_dbed, recvmmended, or
 suggest_ in the p_posed _abeling thereof; or (6) the application failed to con_i_
 . the pa_at i_forma_on prescribed by subsection Co) of this _ec_(m; or (7/) based on a
 fair _alua_on of all mater_s_ facts, such labeling is ffalse o_, misleading in any
 p_dculaz; he shall _sue _ order refusing to approve the application. If, after such
 notice _d opportunity for hearing, the S_cxetary fro& that chuses (1) _rough (6)
 do _o_ apply. _ shall _sue an order app_ovL_g the application. As used in this
 subsec_on and sub_ec_on (e_ of th_ s_ct_o_, the term "substsntial evidence" means
 ev/dence co_g of adequate s_d well_c_ntrolled investigat_o_m, including clinical
 _uvest_g'_on_, by experts qu_fied by scientific training and exl_eisnee to evaluate
 'the effect/veness of the drug _vo[v_d, on the b_is of which it could fairly _d
 _pon_fbby be cuncluded by such exp_rt_ that the drug w_'l] have the effect R
 p_u'po_.= or _ rzi_resen_d _ have under the conditions of use preach'bed, recom-
 -' mendS, or suggested in _e _b_l_ or proposed labeling ther_Ofo
 (s) Wi_hcb._w_ of approve; g_'ou_d_ |mme_a_ _ion upo_ fl_i:tng |mml_u_n_ hazard
 The Seere_ _ha|I, _fter due nonce _d opportunity for hearing to the applicant
 withdraw app_ of an app_cst_oa with re_spect to any drug under this _ection ff
 the Secxetsry "_nds (I) that cff,rdc_l or other exp_fience_ _s_a, or other _z._fie data
 show that auch drug is u_fe for use under the conditions of use upon the basis of

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