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Salt Policy to Avoid Medication Errors

[ Price : $8.95]

CDER pharmacists Catherine Chew and Lindsay Davison say a new USP naming policy for salt drug substances should help reduce medica...

FDA Urged to Speed Biosimilar Developments

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FDA deputy commissioner Sally Howard says that while the agency has been slow in issuing guidance for biosimilars, it is reviewing...

CorMedix Seeks QIDP Designation for Neutrolin

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CorMedix, Inc. files an application with FDA seeking Qualified Infectious Disease designation for its Neutrolin Catheter Lock solu...

Guidance on Pregnancy/Lactation Labeling for Drugs/Biologics

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Federal Register Notice: FDA releases a draft guidance: Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Presc...

FDA Changes Pregnancy Labeling of Drug/Biologics

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Federal Register Final rule: FDA amends its regulations on the content and format of Pregnancy, Labor and delivery, and Nursing mo...

FDA Clears ArtVentive Medical Occlusion System

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FDA clears an ArtVentive Medical Group 510(k) for its Endoluminal Occlusion System that is intended for use in the peripheral vasc...

Incytes Jakafi sNDA Approved for Bone Marrow Disease

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FDA approves an Incyte Corp. supplemental NDA for Jakafi (ruxolitinib) for treating patients with polycythemia vera, a chronic typ...

FDA Clears Fiagon AG Navigation Extended Instrument Set

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FDA clears a Fiagon AG 510(k) for its ear, nose and throat Extended Instrument Set.

FDA Clears GI Views Colonoscope System

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FDA clears a GI View Ltd. 510(k) for its Aer-O-Scope Colonoscope System for colorectal cancer screening.

FDA Holds CytRx Aldoxorubicin Trials

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FDA puts a partial clinical hold on all three trials of CytRxs aldoxorubicin for various cancer indications.FDA puts a partial cli...