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Webinar Explains Indication, Usage Guidance
[2642 Words]
[ Price : $8.95]
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| CDER special assistant for labeling Iris Masucci uses a Webinar to provide detailed information on a draft guidance on the content and format of the Indications and Usage section of labeling for prescription drugs and biologics. |
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10/11/2018
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FDA Clears Transseptal Solutions Access System
[161 Words]
[ Price : $8.95]
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| FDA clears a Transseptal Solutions 510(k) for the TSP Crosser Transseptal Access System, a transseptal puncture system with a built-in steering mechanism. |
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10/11/2018
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Require High-Quality Device Evidence: Blog
[3045 Words]
[ Price : $8.95]
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| Cardiologist Rita Redberg says in a Health Affairs online post that FDA should require high-quality evidence for approval of medical devices. |
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10/11/2018
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Boehringer sNDA for Broader Stiolto Respimat Label OK’d
[151 Words]
[ Price : $8.95]
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| FDA approves a Boehringer Ingelheim supplemental NDA for new labeling on its Stiolto Respimat (tiotropium bromide and olodaterol) that includes data showing a meaningful reduction in chronic obstructive pulmonary disease exacerbations driven by tiotropium. |
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10/11/2018
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Safety Alert on Medtronic Cybersecurity Software Fix
[114 Words]
[ Price : $8.95]
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| FDA issues a safety alert following a Medtronic software update to address a risk caused by cybersecurity vulnerabilities associated with an Internet connection between its Carelink 2090 and Carelink Encore 29901 Programmers that are used to download software for the company’s cardiac implantable electrophysiology devices. |
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10/11/2018
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