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US Report Outlines Nanotech Scientific, Regulatory Challenges

By MedImaging staff writers
Posted on 09 Aug 2007

The U.S. Food and Drug Administration (FDA; Rockville, MD, USA) Nanotechnology Task Force recently released a report that recommends the agency consider developing guidance and taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology.

"Nanotechnology holds enormous potential for use in a vast array of products,” said Commissioner of Food and Drugs Andrew von Eschenbach, M.D., who endorsed the Task Force Report and its recommendations on July 23, 2007. "Recognizing the emerging nature of this technology and its potential for rapid development, this report fosters the continued development of innovative, safe, and effective FDA-regulated products that use nanotechnology materials.”

Scientists and researchers increasingly are working in the nanoscale, creating and using materials and devices at the level of molecules and atoms--1/100,000th the width of a human hair.

The FDA's Task Force Report on Nanotechnology addresses regulatory and scientific issues and recommends the FDA consider development of nanotechnology-associated guidance for manufacturers and researchers. The Task Force was initiated by Commissioner von Eschenbach in 2006.

The Task Force reported that nanoscale materials potentially could be used in most product types regulated by FDA, and that those materials present challenges similar to those posed by products using other emerging technologies. The challenges, however, may be complicated by the fact that properties pertinent to product safety and effectiveness may change as size varies within the nanoscale.

The report also stated that the emerging and uncertain nature of nanotechnology and the potentially rapid development of applications for FDA-regulated products underscore the need for ensuring transparent, consistent, and predictable regulatory pathways.

Foreseeing the potential for rapid development in the field, the report recommends consideration of agency guidance that would clarify, for example, what information to give FDA about products, and also when the use of nanoscale materials may alter the regulatory status of particular products. As with other FDA guidance, draft guidance documents would be made available for public comment prior to being finalized.

Furthermore, the report says the FDA should work to evaluate data needs to better regulate nanotechnology products, including biologic effects and interactions of nanoscale substances. The agency also should develop in-house expertise and ensure consideration of relevant new information on nanotechnology as it becomes available, according to the report. The FDA should evaluate the efficacy of current testing approaches to assess safety, effectiveness, and quality of nanoscale materials.

The FDA and 22 other federal agencies are part of the U.S. National Nanotechnology Initiative, a federal research and development program established to coordinate the multi-agency efforts in nanoscale science, engineering, and technology.

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U.S. Food and Drug Administration

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67 (60.081481933594): select jos_linkedin.link from jos_linkedin where cat=10

68 (257.96890258789): SELECT fid FROM jos_deeppockets WHERE id=250770000 AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE id=250770000 AND published='1' LIMIT 1

69 (359.77363586426): SELECT id,name,sponsor_text FROM jos_deeppockets dp left outer join jos_channel_sponsor cs on dp.id=cs.fid WHERE cat=10 AND TYPE='file_folder' AND published=1 AND id=217 ORDER BY `ordering`

70 (308.03680419922): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=250770000 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

71 (575.06561279297): SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=250770000 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

72 (227.21290588379): SELECT id,name,title FROM jos_deeppockets WHERE cat=10 AND TYPE='file_folder' AND published=1 AND id != 294743300 AND id != 294743301 AND id != 294743302 AND id != 294743303 AND id != 294743304 AND id != 294743305 AND id != 294743306 AND id != 294743307 AND id != 294743308 AND id != 294743309 AND id != 294743310 AND metakey != 'aacc' ORDER BY `ordering`

73 (105.14259338379): SELECT show_live FROM jos_com_show_setting LIMIT 1

74 (59.843063354492): SELECT show_live FROM jos_com_show_setting LIMIT 1

75 (50.067901611328): SELECT show_live FROM jos_com_show_setting LIMIT 1

76 (44.107437133789): SELECT show_live FROM jos_com_show_setting LIMIT 1

77 (46.968460083008): SELECT show_live FROM jos_com_show_setting LIMIT 1

78 (41.961669921875): SELECT show_live FROM jos_com_show_setting LIMIT 1

79 (32.901763916016): SELECT show_live FROM jos_com_show_setting LIMIT 1

80 (35.04753112793): SELECT show_live FROM jos_com_show_setting LIMIT 1

81 (42.915344238281): SELECT show_live FROM jos_com_show_setting LIMIT 1

82 (41.007995605469): SELECT show_live FROM jos_com_show_setting LIMIT 1

83 (44.822692871094): SELECT show_live FROM jos_com_show_setting LIMIT 1

84 (43.153762817383): SELECT show_live FROM jos_com_show_setting LIMIT 1

85 (36.954879760742): SELECT show_live FROM jos_com_show_setting LIMIT 1

86 (36.001205444336): SELECT show_live FROM jos_com_show_setting LIMIT 1

87 (90.122222900391): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=250770000 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

88 (46.968460083008): SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=250770000 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

89 (46.968460083008): SELECT id,name,title FROM jos_deeppockets WHERE cat=10 AND TYPE='file_folder' AND published=1 AND id != 294743300 AND id != 294743301 AND id != 294743302 AND id != 294743303 AND id != 294743304 AND id != 294743305 AND id != 294743306 AND id != 294743307 AND id != 294743308 AND id != 294743309 AND id != 294743310 AND metakey != 'aacc' ORDER BY `ordering`

90 (53.882598876953): SELECT show_live FROM jos_com_show_setting LIMIT 1

91 (30.040740966797): SELECT show_live FROM jos_com_show_setting LIMIT 1

92 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1

93 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1

94 (30.040740966797): SELECT show_live FROM jos_com_show_setting LIMIT 1

95 (24.795532226562): SELECT show_live FROM jos_com_show_setting LIMIT 1

96 (220.06034851074): SELECT show_live FROM jos_com_show_setting LIMIT 1

97 (41.007995605469): SELECT show_live FROM jos_com_show_setting LIMIT 1

98 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1

99 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1

100 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1

101 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1

102 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1

103 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1

104 (115.15617370605): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

105 (72.956085205078): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

106 (105.85784912109): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=250770000 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

107 (54.836273193359): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=250770000 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

108 (936.98501586914): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

109 (!!!!! 2931.8332672119): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

110 (81.062316894531): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=250770000 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

111 (679.96978759766): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=250770000 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

112 (740.05126953125): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1

113 (716.9246673584): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1

114 (!!!!! 4023.0751037598): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

115 (81.062316894531): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

116 (75.101852416992): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

117 (77.962875366211): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

118 (63.896179199219): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

119 (38.862228393555): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

120 (46.968460083008): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

121 (76.055526733398): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

122 (411.03363037109): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`

123 (!!!!! 50447.940826416): SELECT * FROM jos_deeppockets WHERE jos_deeppockets.cat = 10 AND jos_deeppockets.type = 'deeppockets_item' AND jos_deeppockets.published = 1 AND jos_deeppockets.created + INTERVAL 14 DAY >= NOW() ORDER BY jos_deeppockets.hits DESC LIMIT 7

124 (535.01129150391): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=250770000 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=250770000 AND type='deeppockets_item' AND published='1' LIMIT 1

125 (!!!!! 16593.933105469): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3

126 (72.002410888672): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3

127 (41.961669921875): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1

128 (31.948089599609): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1

129 (76.055526733398): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1

130 (40.054321289062): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1

131 (491.85752868652): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1

132 (62.942504882812): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1

133 (51.021575927734): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1

134 (34.093856811523): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1

135 (602.96058654785): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

136 (370.97930908203): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

137 (43.153762817383): SELECT name FROM jos_deeppockets WHERE id=217

138 (30.994415283203): SELECT name FROM jos_deeppockets WHERE id=217

139 (560.99891662598): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))217((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3

140 (541.21017456055): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))217((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3

141 (81.062316894531): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

142 (52.928924560547): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

143 (!!!!! 14078.140258789): TRUNCATE TABLE jos_trademed_module

144 (119.92454528809): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=250770000 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

145 (!!!!! 3417.0150756836): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=250770000 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1

146 (547.88589477539): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

147 (112.77198791504): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1

148 (90.122222900391): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

149 (65.088272094727): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

150 (!!!!! 1230.001449585): SELECT jos_item.* FROM jos_item INNER JOIN jos_number ON jos_item.numberID=jos_number.id WHERE 1=1 AND (jos_item.imgMini<>'') AND jos_item.type='L' AND jos_item.numberID= ( SELECT jos_number.id FROM jos_number WHERE jos_number.journalID IN (10) and jos_number.id in (select distinct jos_number.id from jos_number join jos_item on jos_item.numberid=jos_number.id where jos_item.type='P') ORDER BY (CONVERT(SUBSTRING(issue,1,2),SIGNED) + (CONVERT(SUBSTRING(issue,3,2),SIGNED)*100)) DESC LIMIT 0,1 ) ORDER BY RAND() DESC LIMIT 6

151 (62.227249145508): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

152 (46.014785766602): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

153 (37.193298339844): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=250770000 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=250770000 AND type='deeppockets_item' AND published='1' LIMIT 1

154 (33.140182495117): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=217 or channel_id is null)

155 (28.848648071289): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=217 or channel_id is null)

156 (!!!!! 2902.0309448242): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1

157 (134.94491577148): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

158 (52.928924560547): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=250770000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=250770000 AND published='1' LIMIT 1

159 (46.014785766602): select jos_twitters.link from jos_twitters where cat=10

160 (29.087066650391): select jos_facebook.link from jos_facebook where cat=10

161 (29.802322387695): select jos_google_plus.link from jos_google_plus where cat=10

162 (28.848648071289): select jos_linkedin.link from jos_linkedin where cat=10

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