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7 Observations in Annovex Pharma FDA-483

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FDA releases the form FDA-483 with seven observations issued following an inspection at the Lorton, VA-based Annovex Pharma outsou...

GE Myocardial Perfusion Imaging Agent OKd

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FDA approves GE HealthCares Flyrcado (flurpiridaz F 18) injection, a positron emission tomography myocardial perfusion imaging age...

Siemens PMA for 3D Mammography Platform OKd

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FDA approves a Siemens Healthineers PMA for its tomosynthesis or three-dimensional breast imaging technology for its Mammomat B.br...

Should FDA Place Hold on Troubled Alzheimers Drug?

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The journal Science and other FDA watchers question why FDA does not place a clinical hold on Cassava Sciences investigational Alz...

Guide on Study E-Records/Signatures

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Federal Register notice: FDA makes available a final guidance entitled Electronic Systems, Electronic Records, and Electronic Sig...

Augmentin Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that U.S. Antibiotics Augmentin XR (amoxicillin; clavulanate potassium) extended-release t...

FDA Fast Track for Volastra Ovarian Cancer Drug

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FDA grants fast-track designation to an investigational Volastra drug intended to treat some cases of ovarian cancer

Lab Groups Seek Summary Judgment in LDT Suit

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Two trade associations that oppose FDA regulation of laboratory-developed tests ask a Texas federal court to grant summary judgmen...

Stem Cell Company CEO Gets 36 Months in Jail

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The Justice Department says Liveyon founder and CEO John Kosolcharoen has been sentenced to 36 months in prison after pleading gui...

Fresenius Recalls Ivenix Infusion Pump Software

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Fresenius Kabi recalls (Class 1 device correction) its Ivenix Infusion System Large Volume Pump software due to multiple software ...