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Guide on Combo Product Postmarketing Reporting

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Federal Register notice: FDA makes available a final guidance entitled Postmarketing Safety Reporting for Combination Products Gui...

Medtronic Seeks Non-Adjunctive Label for Insulin Sensor

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Medtronic files a PMA for non-adjunctive labeling for its Guardian Sensor 3, which is part of the MiniMed 670G insulin delivery sy...

PhRMA Lobbying Influencing Administration: Analysis

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Restore Public Trust says the drug industry is setting new records for lobbying spending in an effort to influence the Trump admin...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes High Chemical, Indoco Remedies and Stratus BioSystems.

Bayer Recalls 2 Lots of Kogenate Vials

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FDA says Bayer is recalling two lots of Kogenate FS because some vials contained its Jivi antihemophilic factor rather than Kogena...

FDA Approves Pfizers Rituxan Biosimilar

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FDA approves a Pfizer BLA for Ruxience (rituximab-pvvr), a biosimilar to Biogens Rituxan for three indications.

FDA Approves 9 ANDAs for Generic Lyrica

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FDA approves nine ANDAs for first generics of Pfizers Lyrica for managing neuropathic pain associated with diabetic peripheral neu...

Info Collection on Quick Turnaround Surveys

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Federal Register notice: FDA sends to OMB a proposed information collection for quick turnaround surveys on communication effectiv...

Information Collections Approved by OMB

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Federal Register notice: FDA releases a list of 10 information collections that have been approved by OMB.

Info Extension for Bar Code Label Requirements

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Federal Register notice: FDA submits to OMB an information collection extension for Bar Code Label Requirement for Human Drug and ...