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CDER Webinar on Improving Biosimilar Adoption

[ Price : $8.95]

CDER announces a 4/13 Webinar entitled Biosimilars: A Decade of Experience and Future DirectionsStrategies for Improving Biosimila...

Baxter Safety Alert on Spectrum Infusion Pumps

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Baxter International issues an urgent safety communication on upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusi...

Ferring Wants Restrictions on Firmagon Generics

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Ferring petitions FDA to require in vivo testing for ANDA and follow-on applications citing the companys Firmagon as the reference...

Class 1 Recall of E25Bio Covid-19 Test

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FDA classifies as Class 1 a recall of the E25Bio Covid-19 Direct Antigen Rapid Test because it has not been authorized, cleared, o...

FDA Approves 1st Generic Drug Based on PBPK Model

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FDA says it was able to approve a generic diclofenac sodium topical gel using an alternative method to determine bioequivalence.

People Want More FDA Transparency: Survey

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Johns Hopkins researchers say a survey of U.S. adults shows people want much more transparency from FDA.

FDA Drug Expert Ellis Unger Joins Law Firm

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After retiring from FDA last year, controversial former CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology direc...

FDA Proposes Use of ISO Medical Device Standard

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FDA releases its proposed rule to change the Quality System Regulation by incorporating an international standard.

CytoDyn Promoting Unapproved Drug: OPDP

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The CDER Office of Prescription Drug Promotion warns CytoDyn that a video misbranded its investigational drug leronlimab by making...

Toxicon Violated GLP Regulations: FDA

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FDA warns Toxikon/Labcorp Bedford about violations of Good Laboratory Practice regulations in a clinical study.