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 21 § 355 F(K)D AND DRUGS
 which the application w_ approved; (2) that new evidence of dinica| experience, not
 confined in such appli_on or not available to the Seere_ry until after such
 app[isat_o_ was approved, or tests by new rnetheds, or tests by me.otis not deemed
 reseonab|y applicable when such app]ica_on was approved, evshated together with
 the evidence avaflab|e t_ the Secretory when the applicati_m was spin'eyed, shows
 that such drug is _ot shown _ be safe for use under the cow, tiers of use upon the
 basis of which the application was approved; or {3) on the basis of new information
 before _m with respect to such dn._g, evaluated _gether with _._e e'ddenee available
 to him when the applisafion was approved_ t.hat them is _. lack of substantial
 evidence that the drug will have the effect _t purports or is represented to have
 under the conditions of use prescribed, _ecommende_ or suggested in the _beling
 thereof; or (4} the patent hi.formation presehbed hy subsec_on _e} of this sectkm was
 not filed within thirty days _fter the receipt of written _otice from the Secretary
 specifying the failure t_ file such information; or (5) that the at the application
 contains any untrue sta_mest of a material fact Fro_ded, That if the Secretary (or
 his absence the officer ac_sg as Secretary) finds that _ere _ sn imminent hazard
 the public health, he may suspend the. approvat of such _ppiicat_on immediately,
 and give the applicant prompt no_ce of his action and affol_ the applicant the
 opportunity for an expedited hearing under th_ subsection; but the authority
 conferred by this prv_ _ suspend _he approval of aa app_c_tion shall _ot be
 delegated. The Secretary] may also, after due notice and upper:unity for hearing
 the app]ican_ withdraw the approval of an application submitted under subsec_on _b)
 or {j} of this section with respect _ any drug under this secv_n i._ the Secre_ry finds
 (I} that the applicant has failed to establish s system for mainlining required
 records, or has repeatedly or del_rately failed to maintain such records or to make
 required reports, in accordance _tb a reguhtio_ or order ur_der subsection (k) of
 this section or to c_mpiy w_ the notice requL-ements ef sectmn 360_k_2) of th_
 _e, or the app[_.c,ant has refused to permit access to, or copying or "˘erificcath>n of,
 such records as required by paragraph {2) of such subsection; or (_} that on _e basis
 of _ew inforraatioa before him, evaluated together with _e e_de_ce before him
 when the application w_ approved, the methods used L_, o.r the facilities and
 centro_ used for, the manufacture, processing, sad p_ck_g of such drug are
 inadequate W _ssure and preserve its idenfity_ strength, quality, and purity and were
 not made adequate within a _e_onab_e _me after receipt of _wt_l:_en notice from the
 Secretary spoeify_ng the _tter complained of; or (_ that o_ the basis of aew
 iaformstkm before him, evaluated together w-_ the evidence before him when the
 app_£cs_on was approved, the hbe[ing of s_zeh dragl hosed on a f_.ir evaluation _f all
 material fscts, _ false or mis_e_mg in any par_:/cular and was _t _rrected within a
 reasonable _me after receipt of wr_tte_ notice from the Secre'_y speci_'ing the
 mater complah_ed _fo A_y order under this subsection shall _te the fLnding_ upon
 which it is based.
 [See main _:dumc for t_x_ of (Q_ to (i) ]
 QD Abbr_v_te_ new drug _i|˘_.s
 (D Any person may file with the Secre_ry an abbre'˘_ted _pplica_on for the
 approval of a new drug.
 (_A} An abbreviated applica_on for a new drag shall con_i_
 {D mfo_mat_on to _how that the conditions of use pr_cnq>ed, recommended,
 or suggested in the _be_g prol:_sed for the new drug have been previously
 appr_e_ for a drug _ted under paragraph (6) (hereinafter in this aubs_ction
 referred u_ as a '°link dru_e'_
 (lUll) ff the tired drug referred _ _n chms_ (i) has _ly one active ingredient,
 hformatbu t_ show tl_tt the octave _gredieat of the _ew _h_g _ the same
 that of the listed drug;
 (If) if the _ted drug referred to i_ clave (_ has _ than one _ve
 mgredient_ re.formation tc show that the ac_ve mgvedlents of _e new drug
 the same as those of the _ed drug, or
 (III) ff the l_tt_d chug refereed te ha clause (f_ h_ mo_ than one active
 _n_red_ent and if one of the active mgved_en_ of the new ch_,_g is Afferent _nd
 the app|_c_Son is filed ptu_u_nt t_ the approval of a p_t_on _ under
 subparagraph (_, hfarrn_n to show that _e other _ve _gredients of the
 new drug are the same as _e _etive _mgved_ent_ of the listed drag, h_fo_na_

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