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21 § 355 FoOD ,AND DRUGS i
time afar receipt of written _otice :from the Secretary specifying
mater complained of; or (3) that on the basis of new information
fore him, evaluated together wi_h the evidence before him when
application was approved, the labeling of such drug, based _ a fair
evaluation of all material facts, is false or misleading in any l_.rtie_.
|at and was not corrected within a reasonable time after re_elp_ of
written notice from the Secretary specifying the mater complained _°
Any order under this subsection sha|l state the findings upon which it
is based.
_pp_va| e_ app|le_a˘l@_
(f) Whenever the Secretary finds that the facts so require, he
revoke any previous order under subsection (d)or (e) of this _e˘_.io_
refusing, withdrawing, cr suspending approval of an application aml
shall approve such application or .reinstate such approval, _ m_v b_
appropria_.
(_) Orders of the Secretary issued under this section shall be
.....
served (I) in person by any officer or employee of _he Departm_t
designated by the Secretary or (2) by mailing the order by regmterecl
marl or by certified marl addressed to the applicant or respondent at
his last-known address in the records of the Secre_ryo
(h) An appeal may be taken by the applicant from an order of the
_cre_ary refusing or withdrawing approval of an application under
_his section° Such appeal shall be taken by filins in the United S_t_
court of appeals for the circuit wher'e_n such applicant resides or h_
his _rincii_al place of business, _r in the United States Court of Al_
p_s for the District of Columbia Ci:rcui_, within sixty days aft.r the
..... entry of such order, a written petition praying that the order of the
S_ret_ry be set aside. A copy of _uch petition shall be forthwith
transmitted by the clerk of the court _ the Secre_ry, or any officer
designated by him for that purpose, and thereupon the Secretary shall
certify and file in the court the record upon which the order com-
plained of was entered, as provided in section 2112 of Title 28. U_
the fi|ing of such petition such cour_ shall have exclusive jurisdiction
..... to affirm or set aside such order, except that until the filing of
record _he Secre_ry may modify or _et aside his order. No eb_ect_
to _he order of the Secre_ry shall be considered by the court um_e_
such objection _hall have been urged before the Secretary or u_fl_
there were rea_onsb|e grounds for failure so to doo The finding _f
the Secretary as _o the facts, if _upl_orted by substantial evid_
..... sha|I be eonc|usiveo If any person shall apply to the court for le_ve t_
390
:x..
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