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OMB Approves 11 FDA Info Collections

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Federal Register notice: FDA posts a notification that OMB has approved 11 recent information collections.

CDER to Discuss Quality Management Maturity at Meeting

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CDER plans to review and discuss its proposed Quality Management Maturity program at an 11/2 advisory committee meeting.

Alert on Autoinjectors with Multiple Sclerosis Drugs

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FDA issues a safety alert on autoinjector devices that are optional for use with multiple sclerosis therapy glatiramer acetate inj...

FDA Hold on Pharvaris Hereditary Angioedema Therapy

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FDA issues Pharvaris a clinical hold on two clinical trials of its PHA121, an oral bradykini B2-receptor antagonist for treating a...

Draft Guide on Charging for Investigational Drugs

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FDA releases a revised draft guidance entitled Charging for Investigational Drugs Under an IND: Questions and Answers.

Koag Vascular Closure Pad Cleared

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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...

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...