FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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 ...

Generic Adspec Approved for Bovine Pneumonia

[ Price : $8.95]

FDA approves Bimeda Animal Healths SpectoGard (spectinomycin sulfate), the first generic copy of Pharmacia Animal Healths Adspec....

Mfr. Deficiencies Hamper 1st Cycle ANDA Reviews

[ Price : $8.95]

Writing in a medical journal, CDER researchers say manufacturing-related deficiencies contribute significantly to a low first-revi...

Senate OKs Bill Ending Animal Testing Mandates

[ Price : $8.95]

The Senate unanimously approves legislation to end an FDA mandate for animal testing of experimental drugs before they can be used...

Medtronics Hemostasis Agent Cleared for Upper GI

[ Price : $8.95]

FDA clears a Medtronic 510(k) for its Nexpowder endoscopic hemostasis system.

Amylyx Lou Gehrigs Disease Drug Approved

[ Price : $8.95]

FDA approves Amylyxs amyotrophic lateral sclerosis (ALS; also known as Lou Gehrig's disease) drug AMX0035 (sodium phenylbutyrate a...