FDLI SmartBriefDesigned specifically for professionals involved in the food and drug law community, FDLI SmartBrief is a FREE daily e-mail newsletter. It provides the latest need-to-know news and industry information that maximizes your time, giving you an edge over your competition.&nbsp;Click&nbsp; <a href='http://www.smartbrief.com/fdli/index.jsp?sb_code=rss'>here</a> to subscribe.http://www.smartbrief.com/news/fdli?sb_code=rsshttp://www.smartbrief.com/images/homepage/hed-smartbrief.gifFDLI SmartBriefhttp://www.smartbrief.com/news/fdli?sb_code=rssen-us23 May 2013 08:45:44 CDTSandoz's generic hypertension therapy gets FDA OKhttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D53A2563D-EBDB-4AC5-8B94-41EA9F6FC2CA%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3Drsshttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D53A2563D-EBDB-4AC5-8B94-41EA9F6FC2CA%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3DrssSandoz received federal approval for its candesartan cilexetil tablets to treat certain forms of heart failure in adults with -More- ]]>23 May 2013 08:45:44 CDTDrugs & BiologicsBaxter/Halozyme's HyQvia wins EU nod for immunodeficiencieshttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D648CDCDB-83D6-49D8-8490-B4D75B748BD3%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3Drsshttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D648CDCDB-83D6-49D8-8490-B4D75B748BD3%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3DrssBaxter International and Halozyme Therapeutics obtained approval from the European Commission to market HyQvia as a replaceme -More- ]]>23 May 2013 08:45:44 CDTDrugs & BiologicsDrug compounding and supply chain bill backed by Senate panelhttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D00A9286E-C1CF-41BD-BAF8-C79A96572B2E%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3Drsshttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D00A9286E-C1CF-41BD-BAF8-C79A96572B2E%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3DrssThe Senate Health, Education, Labor and Pensions Committee on Wednesday unanimously voted in favor of a measure that would gi -More- ]]>23 May 2013 08:45:44 CDTDrugs & BiologicsBoehringer vows quick action on manufacturing issues raised by FDAhttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D7027DE20-4031-4B4E-B1A2-98D27266F306%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3Drsshttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D7027DE20-4031-4B4E-B1A2-98D27266F306%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3DrssBoehringer Ingelheim has announced it will act quickly to settle complaints from the FDA over violations at its headquarters  -More- ]]>23 May 2013 08:45:44 CDTDrugs & BiologicsWoodcock: Redefine studies of personalized drugshttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D8F8B308E-6B5C-4A2D-BC22-EEE15AB94474%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3Drsshttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D8F8B308E-6B5C-4A2D-BC22-EEE15AB94474%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3DrssThe FDA will have to change the treatment development process to accelerate the entry of personalized, targeted medications i -More- ]]>23 May 2013 08:45:44 CDTDrugs & BiologicsAbbott's coronary stent clears regulatory hurdle in Europehttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D99340CDA-D84F-4C84-9687-11160D8E8851%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3Drsshttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D99340CDA-D84F-4C84-9687-11160D8E8851%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3DrssRegulators in Europe have granted Abbott approval to market its Xience Xpedition 48 system, which the company says is the "lo -More- ]]>23 May 2013 08:45:44 CDTGlobal FocusALung seeks approval for respiratory-assist device in Chinahttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D0083FEAD-F252-4304-9A4C-42D1D43D2EC0%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3Drsshttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D0083FEAD-F252-4304-9A4C-42D1D43D2EC0%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3DrssALung Technologies is making moves to obtain regulatory approval for its Hemolung respiratory-assist device in China.  -More- ]]>23 May 2013 08:45:44 CDTGlobal FocusGMO labeling law clears Conn. Senatehttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D8690F5EE-8E9E-43C6-B866-61E57A712A36%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3Drsshttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D8690F5EE-8E9E-43C6-B866-61E57A712A36%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3DrssThe Connecticut Senate voted 35-1 in support of legislation to label food containing genetically modified organisms, making i -More- ]]>23 May 2013 08:45:44 CDTFood & Dietary SupplementsFDA seeks to regulate mobile app for urine analysishttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D305A338F-1159-44F6-908A-BFA0601B0B55%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3Drsshttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D305A338F-1159-44F6-908A-BFA0601B0B55%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3DrssThe FDA is asking BioSense Technologies why the company did not submit its mobile application, the uChek Urine Analyzer, to t -More- ]]>23 May 2013 08:45:44 CDTMedical DevicesFDA panel backs proposal to lower regulatory bar for pedicle screwshttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3DED3CB1E2-9F02-49F8-A3D8-CF84A1ED01D2%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3Drsshttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3DED3CB1E2-9F02-49F8-A3D8-CF84A1ED01D2%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3DrssAn FDA proposal to downgrade pedicle screw spinal devices to Class II status has gained support from the agency's Orthopaedic -More- ]]>23 May 2013 08:45:44 CDTMedical Devicesthe LINK: A Comprehensive FDA Directory – print and online editions availablehttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D855A3F2C-25F9-4A95-A09D-8A8341F8CEAD%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3Drsshttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FstoryDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D855A3F2C-25F9-4A95-A09D-8A8341F8CEAD%26brief%3Dfdli%26sb_code%3Drss%26%26campaign%3DrssWith the recent announcements of several key movements at the FDA and HHS, including Deborah M.  -More- 

Assoc Dir/Director, Promotional Regulatory Affairs
Shire

]]>23 May 2013 08:45:44 CDTFDLI Items[T]o meet adverse conditions gracefully, is more than simple endurance; it is an act of aggression, a positive triumph.http://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FquoteDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D99A7020A-A1FB-4450-8CBB-EAAD748E9E58%26brief%3Dfdli%26sb_code%3Drss%26campaign%3Drsshttp://www.smartbrief.com/servlet/rdrc?u=%2Fnews%2FquoteDetails.jsp%3Fissueid%3D24AC9528-4A9F-4278-BFC7-7A7A9B278E55%26copyid%3D99A7020A-A1FB-4450-8CBB-EAAD748E9E58%26brief%3Dfdli%26sb_code%3Drss%26campaign%3DrssThomas Mann,German writer, critic and philanthropist -More- ]]>23 May 2013 08:45:44 CDTSmartQuote