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LivaNova Recall of Blood Pump Controller

[ Price : $8.95]

LivaNova (TandemLife) recalls its LifeSPARC Controller, part of the LifeSPARC blood pump system, due to a software malfunction.

User Fee Reauthorization Signed Into Law

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A bill, which was attached to a continuing resolution, reauthorizing FDAs user fee programs is signed into law by President Biden....

1/3 Accelerated Drugs Have Incomplete Confirmatory Trials

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An HHS Inspector General data snapshot finds that more than one-third of accelerated drug approvals have delinquent confirmatory t...

Clinical Decision Software Guide Expands Oversight: Attorneys

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Attorneys from DLA Piper complain that a new final FDA guidance on Clinical Decision Support (CDS) Software appears to be more exp...

Eugia Recalls 1 Lot of Acyclovir Sodium Injection

[ Price : $8.95]

Eugia U.S. (formerly AuroMedics Pharma) recalls one lot of acyclovir sodium injection 500 mg per 10 mL single dose vials due to a ...

Radiology Display Device Submission Guidance

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FDA publishes a guidance on preparing 510(k) submissions for display devices intended for diagnostic radiology.

Medical Device Data Systems Guidance

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FDA publishes a revised guidance on medical device data systems to conform with the 21st Century Cures Act.

Animal Drug Application Actions Posted

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Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug applica...

Meeting on Animal Generic Drug User Fees

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Federal Register notice: FDA announces a 10/26 public meeting entitled Animal Generic Drug User Fee Act.

FDA in New AMP Heart Failure Program

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FDA joins with the NIH and other organizations in a new Accelerating Medicines Partnership program on heart failure.