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Draft Guide on Charging for Investigational Drugs

[ Price : $8.95]

FDA releases a revised draft guidance entitled Charging for Investigational Drugs Under an IND: Questions and Answers.

Koag Vascular Closure Pad Cleared

[ Price : $8.95]

FDA clears a Koag 510(k) for its Vascette HP device, a topical vascular closure pad that uses a proprietary, plant-derived hemosta...

NIHs Fauci Stepping Down At End of Year

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After 38 years as National Institute of Allergy and Infectious Diseases (NIAID) director, Anthony Fauci says he will be stepping d...

Device GMP Info Collection Extension

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

Info Collection on CDRH Appeals Processes

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

FDA, European Regulators Back GCP Inspection Collaboration

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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

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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

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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

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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

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