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Review Period for Biomarin’s Palynziq
[97 Words]
[ Price : $8.95]
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| Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Biomarin Pharmaceutical’s Palynziq (pegvaliase-pqpz). |
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12/06/2019
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Draft Guide on Corticosteroid Products for Hemorrhoids
[114 Words]
[ Price : $8.95]
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| FDA releases a draft guidance entitled “Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids.” |
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12/06/2019
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Amgen’s Remicade Biosimilar Gains Approval
[87 Words]
[ Price : $8.95]
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| FDA approves an Amgen BLA for Avsola (infliximab-axxq), a biosimilar of Janssen’s Remicade, indicated for treating Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. |
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12/06/2019
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Increased Enforcement on Violative Cell/Tissue Products
[471 Words]
[ Price : $8.95]
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| FDA steps up its enforcement efforts against violative cell/tissue products, and issues warnings against Liveyon Labs on the heels of similar actions against others earlier this month. |
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12/06/2019
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Physician Convicted in Insy Therapeutics Scheme
[227 Words]
[ Price : $8.95]
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| A federal court convicts New York physician Gordon Freedman for participating in a scheme to receive bribes and kickbacks through sham educational programs from Insys Therapeutics in exchange for prescribing millions of dollars’ worth of Subsys. |
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12/06/2019
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2 Pain Drug NDAs Head to Panel
[148 Words]
[ Price : $8.95]
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| Federal Register notice: FDA announces a 1/15/2020 Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee joint meeting to discuss two pain NDA submissions. |
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12/06/2019
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FDA Seeking NDMA Testing
[2754 Words]
[ Price : $8.95]
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| FDA asks manufacturers of Zantac and Axid to test for NDMA impurities and not release lots that are above the acceptable daily limit. |
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12/05/2019
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Dietary Supplement GMPs Info Collection
[116 Words]
[ Price : $8.95]
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| Federal Register notice: FDA is seeking comments on an information collection revision for Dietary Supplements good manufacturing practices. |
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12/05/2019
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Cell/Tissue Product Registration Info Collection
[98 Words]
[ Price : $8.95]
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| Federal Register notice: FDA seeks comments on an information collection extension for “Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing.” |
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12/05/2019
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