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Medtronic Modifies Software for HeartWare Pump Problem

[ Price : $8.95]

Medtronic announces that a backup controller with modified software can be used if the primary controller fails to restart its Hea...

Guide on Acute Myeloid Leukemia Therapies

[ Price : $8.95]

FDA makes available a final guidance entitled Acute Myeloid Leukemia (AML): Developing Drugs and Biological Products for Treatment...

Data Submissions for Imported Veterinary Devices

[ Price : $8.95]

Federal Register notice: FDA amends its regulations to require that certain data elements be submitted for veterinary devices that...

Review on Biogen Lou Gehrigs Drug Extended

[ 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...

2 Inspection Program Guides Revised

[ 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...

Missed Opportunity on FDA Reforms: Ex-Commissioners

[ Price : $8.95]

Former FDA commissioners Mark McClellan and Scott Gottlieb say the recent user fee reauthorization was a profound missed opportuni...

Guide on Comparability Protocols

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Comparability Protocols for Postapproval Changes to the Che...

Guide on ANDA Prior Approval Supplements

[ Price : $8.95]

FDA releases a final guidance entitled ANDA Submissions Prior Approval Supplements (PAS) Under GDUFA.

Ulrich Medical 3D-printed Flux-C Cleared

[ Price : $8.95]

FDA clears an Ulrich Medical 510(k) for its Flux-C 3D-printed porous titanium cervical interbody device.

FDA Assessing NDA/BLA Information Requests

[ Price : $8.95]

Federal Register notice: FDA announces an opportunity for public comment on a statement of work to assess communication between FD...