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Device GMP Info Collection Extension

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Devices: Current Good Manufact...

FDA, European Regulators Back GCP Inspection Collaboration

[ Price : $8.95]

A new research article by FDA and European regulators finds their good clinical practice inspection processes to be equivalent, wh...

Medtronic Defibrillator Recall is Class 1

[ Price : $8.95]

FDA classifies as Class 1 a recent Medtronic recall of its Cobalt/Crome implantable cardioverter defibrillators and resynchronizat...

FDA Revamping Inspection Planning System, Other Changes: Report

[ Price : $8.95]

A new FDA report on Covid-19 activities notes that the agency is initiating a new inspection planning system that will be more eff...

FDA Cites Sun Pharma Over GMP Violations

[ Price : $8.95]

A just-completed FDA inspection of Sun Pharmaceutical Industries Punjab, India manufacturing facility leads to a six-item Form FDA...

Cipla India Plant Receives FDA-483

[ Price : $8.95]

FDA sends India-based Cipla Ltd. a two-item Form FDA-483 after a recent inspection at its Madhya Pradesh, India manufacturing plan...

Pfizer Required to Conduct Paxlovid Covid Rebound Trial

[ Price : $8.95]

FDA revises a Pfizers emergency use authorization for Paxlovid (nirmatrelvir co-packaged with ritonavir) for treating mild-to-mode...

Visibly At-Home Vision Test Cleared

[ Price : $8.95]

FDA clears a Visibly 510(k) for its Visibly Digital Acuity Product (VDAP), an at-home digital vision testing platform for determin...

Info Collection on CDRH Appeals Processes

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Center for Devices and Radiological Health ...

False Claims Act Used in Off-Label Cases: Attorney

[ Price : $8.95]

Attorney Keeley McCarty warns medical device manufacturers that the government is pursuing False Claims Act cases against companie...