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Info Collection on Patent Restoration Petitions

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Federal Register notice: FDA seeks comments on an information collection extension entitled Patent Term Restoration; Due Diligence...

QS, Other Violations at Zyno Medical

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FDA warns Natick, MA-based Zyno Medical about Quality System and other violations in its production of infusion pumps and administ...

FDA Clears Bodyport Cardiac Fluid Scale

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FDA clears a Bodyport 510(k) for its biomarker platform Bodyport Cardiac Scale that is intended to assess measures of heart functi...

CorMedix Hit With 2nd Complete Response on DefenCath

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FDA sends CorMedix a second complete response letter on its NDA for DefenCath (taurolidine/heparin catheter lock solution) for use...

Objectionable Conditions at Valley Biosystems

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FDA warns West Sacramento, CA-based Valley Biosystems about violations in its conduct of two nonclinical laboratory studies.

QS, MDR Violations at InfuTronix

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FDA warns Natick, MA-based Infutronix about Quality System and Medical Device Reporting violations in its production of infusion p...

EUA for Modified Administration of Monkeypox Vaccine

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FDA issues Bavarian Nordic an emergency use authorization for its smallpox/monkeypox vaccine Jynneos to allow healthcare providers...

Understanding Drug Risks and Benefits in Tweets

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CDER advertising researchers say their study of character-space-limited communications like Tweets in terms of drug benefit and ri...

Amazon Distributing Unapproved New Drugs: FDA

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FDA warns Amazon.com that its fulfillment service is distributing unapproved new drugs sold over-the-counter as mole and skin tag ...

FDA Extends Review of Reata Pharma NDA

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FDA extends by three months the review of a Reata Pharmaceuticals NDA for omaveloxolone to allow time to evaluate additional data ...