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Suit Seeks Info on Any Sharpless Drug Conflict
[420 Words]
[ Price : $8.95]
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| Watchdog group Restore Public Trust files suit to get FOI documents on whether FDA acting commissioner Ned Sharpless is asserting any influence at the agency to advance a drug being developed by a firm he cofounded. |
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08/09/2019
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FDA Tests New BE Method for Generic Topicals
[353 Words]
[ Price : $8.95]
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| A new FDA Impact Story discusses new research undertaken to help would-be generic topical dermatological drug product developers demonstrate bioequivalence. |
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08/09/2019
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Amarin Expects Review Extension on Vascepa sNDA
[313 Words]
[ Price : $8.95]
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| Amarin says FDA likely will extend its review of a supplemental NDA seeking an expanded indication for Vascepa (icosapent ethyl) capsules after revealing that it plans to hold an advisory committee meeting 11/14 on the submission. |
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08/09/2019
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Endologix Study for Aortic Aneurysms Device
[202 Words]
[ Price : $8.95]
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| FDA gives Endologix authorization to begin a pivotal study to evaluate the safety and effectiveness of its Nellix Chimney EndoVascular Aneurysm Sealing System. |
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08/09/2019
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AveXis Inspection Observations
[2379 Words]
[ Price : $8.95]
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| FDA releases the FDA-483 with five inspection observations issued following an inspection at the AveXis control testing laboratory. |
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08/08/2019
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Panel Backs Descovy for Preventing HIV in Men
[229 Words]
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| An FDA advisory committee has voted 16-2 to recommend approval for Gilead Sciences’ HIV drug Descovy for pre-exposure prophylaxis (PrEP) in men and transgender women, but not for cisgender women. |
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08/08/2019
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