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Thirteen patient and consumer health advocacy organizations question the wisdom of allowing companies to market regulated products...[ Price : $8.95]
FDA moves drug safety labeling changes to a CDER database to speed publication of the data.[ Price : $8.95]
CDRH posts a guidance on Submission of 510(k)s for Solid State X-ray Imaging Devices that outlines the type of data to establish t...[ Price : $8.95]
FDA approves a Medtronic PMA for the Enlite sensor for use with iPro2 Professional Continuous Glucose Monitoring system.[ Price : $8.95]
FDA grants Perrigo tentative ANDA approval for a generic version of Gladermas Epiduo Gel (adapalene and benzoyl peroxide 0.1%/2.5%...[ Price : $8.95]
FDA accepts for review an Array BioPharma NDA for binimetinib for treating certain patients with melanoma.[ Price : $8.95]
FDA issues a safety alert for lab staff and health care professionals about a software defect in Sciex mass spectrometers.[ Price : $8.95]
Federal Register Notice: FDA renews the charter of the Cardiovascular and Renal Drugs Advisory Committee for an additional two yea...