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TXT Life Spine Plateau-A Lumbar Spacer Cleared [80 Words] [ Price : $8.95]
FDA clears a Life Spine 510(k) for the Plateau-A Ti Anterior Lumbar Spacer System, intended for use for anterior fusion procedures.
08/05/2020
 
 
TXT CME America Recalls BodyGuard Infusion Pump [143 Words] [ Price : $8.95]
CME America recalls its BodyGuard Infusion Pump System due to infusion errors.
08/05/2020
 
 
TXT Siemens Somatom Mobile CT Scanner Cleared [109 Words] [ Price : $8.95]
FDA clears a Siemens Healthineers 510(k) for the Somatom On.site, a mobile head computed tomography scanner.
08/05/2020
 
 
TXT AbbVie Ends Voyager Therapy Development Pact [2703 Words] [ Price : $8.95]
Voyager Therapeutics says AbbVie has ended two agreements under which Voyager was to research and develop treatments for Alzheimer’s, Parkinson’s, and other diseases and conditions.
08/05/2020
 
 
TXT Rare Disease Clinical Trial Networks [3002 Words] [ Price : $8.95]
Three industry and patient stakeholders express support for the creation of one or more rare disease clinical trial networks.
08/05/2020
 
 
TXT Combo Product Constituent Part Applicant Info Collection [82 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension for “Postmarketing Information Sharing Among Constituent Part Applicants for Combination Products — 21 CFR 4.103.”
08/05/2020
 
 
TXT Combo Products Office Pilots eSubmission Process [88 Words] [ Price : $8.95]
Federal Register notice: FDA seeks applicants to participate in an Office of Combination Products voluntary pilot program to help it evaluate a new electronic submissions process for Requests for Designation.
08/05/2020
 
 
TXT FT 2021 User Fee Rates for Outsourcing Facilities [96 Words] [ Price : $8.95]
Federal Register notice: FDA announces fiscal year 2021 user fee rates for the establishment and re-inspection fees for entities that compound human drugs.
08/05/2020
 
 
TXT Comments on FDA Data Strategy Modernization [2929 Words] [ Price : $8.95]
Four stakeholders comment on early FDA plans to modernize its data strategy.
08/05/2020
 
 
TXT MasterPharm FDA-483 Released [2714 Words] [ Price : $8.95]
FDA releases an FDA-483 with seven observations from its inspection at MasterPharm, a producer of sterile and non-sterile drug products.
08/05/2020
 
 
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