PharmaLeaders - FDA Update http://pharmaleaders.com/ Sun, 05 Sep 2010 17:37:28 +0000 FeedCreator 1.7.3 http://pharmaleaders.com/images/M_images/joomla_rss.png PharmaLeaders - FDA Update http://pharmaleaders.com/ Joomla! site syndication Federal Register: Guidance for Industry and Food a... http://pharmaleaders.com/index.php?option=com_content&view=article&id=246239:Federal%20Register:%20Guidance%20for%20Industry%20and%20Food%20and%20Drug%20Administration%20Staff;%20Impact-Resistant%20Lenses:%20Questions%20and%20Answers;%20Availability.&catid=55:FDA http://pharmaleaders.com/index.php?option=com_content&view=article&id=246239:Federal%20Register:%20Guidance%20for%20Industry%20and%20Food%20and%20Drug%20Administration%20Staff;%20Impact-Resistant%20Lenses:%20Questions%20and%20Answers;%20Availability.&catid=55:FDA The FDA is announcing the availability of the guidance entitled 'Impact-Resistant Lenses: Questions and Answers.' This guidance document answers manufacturer, importer, and consumer questions on impact-resistant lenses, including questions on test...
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]]> Administrator Fri, 03 Sep 2010 05:01:59 +0000 Office of Device Evaluation Annual Performance Rep... http://pharmaleaders.com/index.php?option=com_content&view=article&id=245910:Office%20of%20Device%20Evaluation%20Annual%20Performance%20Report%20Fiscal%20Year%202009&catid=55:FDA http://pharmaleaders.com/index.php?option=com_content&view=article&id=245910:Office%20of%20Device%20Evaluation%20Annual%20Performance%20Report%20Fiscal%20Year%202009&catid=55:FDA In the past, the ODE Annual Report included information from and about the ODE Review Divisions, our initiatives, and data analysis from the ODE Program Operations Staff (POS). The FY 09 Report only includes data from POS on our premarket review program.
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]]> Administrator Thu, 02 Sep 2010 17:02:29 +0000 Guidance for Industry and FDA Staff - Impact-Resis... http://pharmaleaders.com/index.php?option=com_content&view=article&id=245909:Guidance%20for%20Industry%20and%20FDA%20Staff%20-%20Impact-Resistant%20Lenses:%20Questions%20and%20Answers&catid=55:FDA http://pharmaleaders.com/index.php?option=com_content&view=article&id=245909:Guidance%20for%20Industry%20and%20FDA%20Staff%20-%20Impact-Resistant%20Lenses:%20Questions%20and%20Answers&catid=55:FDA Eyeglasses and sunglasses (eyewear) that are intended to affect the structure or function of the body or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, are devices...
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]]> Administrator Thu, 02 Sep 2010 17:02:27 +0000 Federal Register: Public Workshop on Medical Devic... http://pharmaleaders.com/index.php?option=com_content&view=article&id=245391:Federal%20Register:%20Public%20Workshop%20on%20Medical%20Devices%20and%20Nanotechnology:%20Manufacturing,%20Characterization,%20and%20Biocompatibility%20Considerations;%20Correction.&catid=55:FDA http://pharmaleaders.com/index.php?option=com_content&view=article&id=245391:Federal%20Register:%20Public%20Workshop%20on%20Medical%20Devices%20and%20Nanotechnology:%20Manufacturing,%20Characterization,%20and%20Biocompatibility%20Considerations;%20Correction.&catid=55:FDA The FDA is correcting a notice that appeared in the Federal Register of August 23, 2010 (75 FR 51829). The notice announced the public workshop entitled 'Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility...
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]]> Administrator Wed, 01 Sep 2010 17:02:17 +0000 Federal Register: Medical Device User Fee Act; Pub... http://pharmaleaders.com/index.php?option=com_content&view=article&id=245390:Federal%20Register:%20Medical%20Device%20User%20Fee%20Act;%20Public%20Meeting;%20Request%20for%20Comments;%20Amendment%20of%20Notice&catid=55:FDA http://pharmaleaders.com/index.php?option=com_content&view=article&id=245390:Federal%20Register:%20Medical%20Device%20User%20Fee%20Act;%20Public%20Meeting;%20Request%20for%20Comments;%20Amendment%20of%20Notice&catid=55:FDA The FDA is announcing an amendment to the notice of a public meeting on the reauthorization of the medical device user fee program. This meeting was announced in the Federal Register of August 13, 2010 (75 FR 49502). The amendment is being made to...
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