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TXT Review Period for Biomarin’s Palynziq [97 Words] [ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Biomarin Pharmaceutical’s Palynziq (pegvaliase-pqpz).
12/06/2019
 
 
TXT Draft Guide on Corticosteroid Products for Hemorrhoids [114 Words] [ Price : $8.95]
FDA releases a draft guidance entitled “Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids.”
12/06/2019
 
 
TXT Magnetic Resonance Coil Performance Criteria Guide [181 Words] [ Price : $8.95]
FDA posts a draft guidance on “Magnetic Resonance (MR) Coil – Performance Criteria for Safety and Performance Based Pathway.”
12/06/2019
 
 
TXT Amgen’s Remicade Biosimilar Gains Approval [87 Words] [ Price : $8.95]
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.
12/06/2019
 
 
TXT Increased Enforcement on Violative Cell/Tissue Products [471 Words] [ Price : $8.95]
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.
12/06/2019
 
 
TXT Physician Convicted in Insy Therapeutics Scheme [227 Words] [ Price : $8.95]
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.
12/06/2019
 
 
TXT 2 Pain Drug NDAs Head to Panel [148 Words] [ Price : $8.95]
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.
12/06/2019
 
 
TXT FDA Seeking NDMA Testing [2754 Words] [ Price : $8.95]
FDA asks manufacturers of Zantac and Axid to test for NDMA impurities and not release lots that are above the acceptable daily limit.
12/05/2019
 
 
TXT Dietary Supplement GMPs Info Collection [116 Words] [ Price : $8.95]
Federal Register notice: FDA is seeking comments on an information collection revision for Dietary Supplements good manufacturing practices.
12/05/2019
 
 
TXT Cell/Tissue Product Registration Info Collection [98 Words] [ Price : $8.95]
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.”
12/05/2019
 
 
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