[ 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...[ Price : $8.95]
Former FDA commissioners Mark McClellan and Scott Gottlieb say the recent user fee reauthorization was a profound missed opportuni...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Comparability Protocols for Postapproval Changes to the Che...[ Price : $8.95]
FDA releases a final guidance entitled ANDA Submissions Prior Approval Supplements (PAS) Under GDUFA.