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TXT ViiV Files NDA for HIV Drug [130 Words] [ Price : $8.95]
ViiV Healthcare files an NDA for fostemsavir, an investigational, first-in-class attachment inhibitor for treating HIV-1 infection.
12/05/2019
 
 
TXT Nonvoting Device Industry Reps for Panels Sought [73 Words] [ Price : $8.95]
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.
12/05/2019
 
 
TXT CDRH, CDER Differ on Releasing Gender Info [2999 Words] [ Price : $8.95]
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.
12/05/2019
 
 
TXT FDA Authorizes Roche MRSA Detection Test [2758 Words] [ Price : $8.95]
FDA authorizes Roche to market its cobas vivoDX MRSA diagnostic test that speeds the detection of MRSA using new technology.
12/05/2019
 
 
TXT Chara Biologics Markets Unapproved Cell Product: CBER [2698 Words] [ Price : $8.95]
CBER says Chara Biologics is marketing its CharaCore cell product to treat serious diseases and conditions without agency approval.
12/05/2019
 
 
TXT FDA Approves 3 ANDAs for Generic MS Drug [173 Words] [ Price : $8.95]
FDA approves three ANDAs for the first generics of Novartis’ Gilenya (fingolimod) capsules for treating relapsing forms of multiple sclerosis in adult patients.
12/05/2019
 
 
TXT FDA Launches CURE ID Internet Repository [2743 Words] [ Price : $8.95]
FDA launches its CURE ID Internet-based repository for reporting experiences using approved drugs in new ways to treat hard-to-treat diseases.
12/05/2019
 
 
TXT Genus Lifesciences Protests FDA Actions on Lannett Application [2834 Words] [ Price : $8.95]
Genus calls on FDA to rescind its acceptance of a Lannett 505(b)(2) application for a cocaine hydrochloride product.
12/05/2019
 
 
TXT Groups Question FDA Weight Loss Paper [2736 Words] [ Price : $8.95]
Several professional groups take issue with provisions in an FDA discussion paper on a benefit/risk approach for medical devices for weight loss.
12/05/2019
 
 
TXT Guide on Interstitial Cystitis/Bladder Pain Syndrome [76 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment.”
12/05/2019
 
 
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