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 9 FOOD, VRUG, AnD COSMETIC Act 21 § 355
 effect it purports or is represented to have under the conditior_ of use
 l_re_cribed , r_mmended, or suggesg_d in the labeling or proposed _o
 _i_g _ereofo
 Wi_bc1_we] mf epp_ova_e _nd_a lea_e_e e_ie_ _pem _d|m_
 (e) The Secretary shall, after due notice and opportunity for hear-
 to the applicant, withdraw spproval of an application with respect
 W _ny drug under this section if the Secretary finds (I) that clinical
 or other experience, tests, or other scientific data show that such drug
 unsafe for use under the conditions of use upon the basis of which i
 the application was approved; (S) that new evidence of clinical expe_ !
 _ence, not confined in such application or not available to the Seers-
 _try until slier such application was approved, or tests by new moth°
 _Is, or test8 by methods not deemed reasonably applicable when such
 _pplicstion was approved, evaluated together with the evidence availa-
 ble to the Secre_ry when the application was approved, shows that
 _uch drug is _ot shown to be emfe for use under the conditions of use
 ul_n the basis of which the app|icstion was approved; or (3) on the
 basis of new information before him with respect _ such drug, eva|u-
 sted together with the evidence avai|abie to him when the application
 _ approved, t_t there is a lack of substantial evidence that the
 &ug will have _he effect _ purports or is represented to have under
 the conditions of use prescribed, recommended, or suggested in the la-
 beling thereof; or (4) that the application contains any untrue state-
 meat of a material fact: Prov/d_d, That if the Secretary (or in his ab_
 ence the officer acting as Secretary) :finds that there ia an imminent
 _rd _ the public health, he may suspend the approval of such ap-
 pl_cstio_ immddiately, and give the applicant prompt notice of his ac-
 tion and afford the applicant the opportunity for an expedited hear-
 _g under this subsec_ion_ but the authority conferred by this proviso
 suspend the approva_ of an application shall not be delegated, The
 _ecretary may also, after due notice and opportunity for hearing to
 _e _pplicant, withdraw the approval of an application with respect to
 _y drug under this section if the Secre_ry finds (1) that the appli-
 er has failed _ establish a system for maintaining required records,
 ...... or has repeatedly or deliberately fai|ed to maintain such records or to
 make required reports, in accordance with a regulation or order under
 subsection (j) of this section, or the applicant has refused to permit
 access _, or copying or verification of, such records _ required by
 l_aragvaph (2) of such subsection; or (_D that on the basis of new ins
 . formation before him, evaluated together with the evidence before him
 when the application was approved_ the methogm used in, or the faeili°
 ...... _ies and controls used ford the manufacture, processing, and packing of "
 such drug are inadequate to a_u_ and preserve its identity, strength,
 quality, _nd purity and were not made adequate within a re_sonable
 $S$