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Guidance on Cigar Warning Plans

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Submission of Warning Plans for Cigars.

Guidance on Reducing Zika Transmission by Blood/Blood Components

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Bloo...

FDA Amends Drug Registration/Listing Regulations

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Federal Register Final rule: FDA amends its regulations on drug establishment registration and drug listing for finished drug prod...

FDA Clears Siemens Somatom Drive CT System

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FDA clears a Siemens 510(k) for the Somatom Drive computed tomography system, a new dual source scanner designed to deliver more p...

FDA Schedules Sentinel PRISM 12/7 Workshop

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FDA schedules a workshop on its PRISM vaccine evaluation program that is part of the Sentinel Initiative.

FDA Approves Genmab Supplemental BLA for Arzerra

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FDA approves a Genmab supplemental BLA for the use of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide fo...

Senators Ask Standards Group for UDI Use

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Sens. Grassley and Warren ask the Accredited Standards Committee X12 for a staff briefing on efforts to include unique device iden...

Appeals Court Backs Lanx in Spinal Device Case Dismissal

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The 5th Circuit Appeals Court agrees with a lower courts grant of summary judgment dismissing claims against Lanx over an implante...

QS, MDR Violations at Simpro

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FDAs Dallas District Office warns Simpro about Quality System, MDR and Web site violations in its importation and distribution of ...

CGMP Violations at 2 Xinxiang Facilities

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FDA warns Chinas Xinxiang Pharmaceutical and Xinxiang Tuoxin Biochemical about CGMP violations in the manufacturing of active phar...