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Garmendia Permanently Debarred Over Trial Fraud

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Federal Register notice: FDA rejects a request for a hearing submitted by Bernardo Garmendia, and issues an order permanently deba...

CareFusion Recalls BD Alaris Systems Manager

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Becton Dickinsons CareFusion unit recalls its BD Alaris Systems Manager due to software issues that could provide incorrect therap...

Korro Bio Gets Orphan Status for KRRO-110

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FDA awards Korro Bio an orphan drug designation for KRRO-110 for treating Alpha-1 Antitrypsin Deficiency.

FDA Panel Determines Next Flu Vaccine Composition

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FDA convenes a non-public interagency meeting to adopt recommendations for vaccine manufacturers and the virus strains to be used ...

Dr. Reddys Recalls Mislabeled Seizure Drug

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Dr. Reddys Laboratories recalls one lot of levetiracetam in 0.75% sodium chloride injection, 1,000 mg/100 mL single-dose infusion ...

Smiths Medical Recalls Endotracheal Tube

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Smiths Medical recalls its Portex Endotracheal Tube because some devices have a smaller diameter than expected and may result in i...

FDA Top Lawyer Resigns After 2 Days on the Job

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Just-appointed FDA chief counsel Hilary Perkins abruptly resigns her post after two days on the job.

SpringWorks Therapeutics Awarded Priority Voucher

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Federal Register notice: FDA issues a priority review voucher was issued to SpringWorks Therapeutics for achieving a 2/11 NDA appr...

QApel Selling Unapproved Aspiration System: FDA

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FDA warns Fremont, CA-based QApel Medical about illegally marketing an aspiration system with Quality System Regulation violations...

One-third of MAUDE Reports Submitted Late: Study

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Researchers say that nearly one-third of adverse event reports submitted to the FDA MAUDE medical device database came in later th...