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FDA posts a draft guidance entitled Tissue Agnostic Drug Development in Oncology. The document provides recommendations to sponsor...[ Price : $8.95]
Federal Register notice: FDA issues an order permanently debarring Gregory Settino from providing services related to an approved ...[ Price : $8.95]
FDA posts a draft guidance entitled Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunoth...[ Price : $8.95]
Medtronic announces that a backup controller with modified software can be used if the primary controller fails to restart its Hea...[ Price : $8.95]
FDA makes available a final guidance entitled Acute Myeloid Leukemia (AML): Developing Drugs and Biological Products for Treatment...[ Price : $8.95]
Federal Register notice: FDA amends its regulations to require that certain data elements be submitted for veterinary devices that...[ Price : $8.95]
FDA extends by three months its review of an NDA for Biogens tofersen, an investigational new drug intended to treat superoxide di...[ Price : $8.95]
FDA revises two compliance programs on inspections effective 10/17 CP 7346.832 Preapproval Inspections and CP 7356.002 Drug GMP s...