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Ventripoint Modifies 510(k) with FDA-requested Clinical Data

[ Price : $8.95]

Ventripoint Diagnostics files FDA-requested clinical data to support an earlier 510(k) for the Ventripoint Medical System for use ...

Contract Testing Labs Under FDA Drug Compounding Scrutiny

[ Price : $8.95]

A Washington Post article examines increased scrutiny by FDA of contract testing labs because they have played a large role in all...

Atossa Genetics Recalls ForeCYTE Breast Health Test

[ Price : $8.95]

Atossa Genetics recalls its ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test device from the market.

FDA Clears Binder Biomedical Spinal Fusion Device

[ Price : $8.95]

FDA clears a Binder Biomedical 510(k) for its Logic System, a stand-alone intervertebral body fusion device.

The IMMPACT Affair and FDAs Institutional Forgettory

[ Price : $8.95]

FDA Webview editor Jim Dickinson reviews two news exposs about FDA participation in closed, drug industry-funded meetings about im...

Judge Shields Most Info in Corp. Integrity Agreements from FOIA

[ Price : $8.95]

A federal judge rules that information about corporate sales and marketing violations that are required to be disclosed to the gov...

Orphan Status for GT Biologics Pediatric Crohns Therapy

[ Price : $8.95]

FDA grants GT Biologics an orphan drug designation for Thetanix (bacteroides thetaiotaomicron) for treating pediatric Crohns disea...

FDA, Cell Therapeutics Agree on Special Protocol

[ Price : $8.95]

FDA and Cell Therapeutics reach agreement on a Special Protocol Assessment for a planned pivotal Phase 3 clinical trial known as t...

CEL-SCI Signs with U.S. Navy for Multikine Study

[ Price : $8.95]

CEL-SCI Corp. signs a research agreement with the U.S. Naval Medical Center in San Diego to conduct a Phase 1 study of Multikine i...

Baxter Clinolipid Approved for Parenteral Nutrition

[ Price : $8.95]

FDA approves a Baxter healthcare NDA for Clinolipid (lipid injectable emulsion, USP) for intravenous feeding (parenteral nutrition...