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ViiV Files NDA for HIV Drug
[130 Words]
[ Price : $8.95]
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| ViiV Healthcare files an NDA for fostemsavir, an investigational, first-in-class attachment inhibitor for treating HIV-1 infection. |
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12/05/2019
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Nonvoting Device Industry Reps for Panels Sought
[73 Words]
[ Price : $8.95]
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| Federal Register notice: FDA requests that any industry organizations interested in participating in selecting nonvoting industry representatives to serve on certain Medical Devices Advisory Committee panels notify the agency in writing. |
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12/05/2019
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CDRH, CDER Differ on Releasing Gender Info
[2999 Words]
[ Price : $8.95]
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| An International Consortium of Investigative Journalists report finds that unlike CDER, CDRH refuses to make public MAUDE data on patients’ sex, age, and other elements that researchers need to better understand the differences in the way women and men react to medical devices. |
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12/05/2019
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FDA Authorizes Roche MRSA Detection Test
[2758 Words]
[ Price : $8.95]
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| FDA authorizes Roche to market its cobas vivoDX MRSA diagnostic test that speeds the detection of MRSA using new technology. |
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12/05/2019
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FDA Approves 3 ANDAs for Generic MS Drug
[173 Words]
[ Price : $8.95]
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| FDA approves three ANDAs for the first generics of Novartis’ Gilenya (fingolimod) capsules for treating relapsing forms of multiple sclerosis in adult patients. |
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12/05/2019
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FDA Launches CURE ID Internet Repository
[2743 Words]
[ Price : $8.95]
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| FDA launches its CURE ID Internet-based repository for reporting experiences using approved drugs in new ways to treat hard-to-treat diseases. |
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12/05/2019
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Groups Question FDA Weight Loss Paper
[2736 Words]
[ Price : $8.95]
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| Several professional groups take issue with provisions in an FDA discussion paper on a benefit/risk approach for medical devices for weight loss. |
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12/05/2019
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Guide on Interstitial Cystitis/Bladder Pain Syndrome
[76 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available a draft guidance entitled “Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment.” |
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12/05/2019
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