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Baxter Recalls Volara Circuits, Adapter

[ Price : $8.95]

Baxter recalls (Class 1) certain Volara Single Patient Use Circuits and Blue Ventilator Adapter Assemblies due to reports that the...

Flagyl Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Pfizers Flagyl (metronidazole) tablets, 250mg and 500mg, were not withdrawn due to sa...

Comments on ICH RWD Studies Guidance

[ Price : $8.95]

Two industry associations give line-by-line comments and edits on an International Council for Harmonization draft guidance on the...

Labs Ask Court to Throw Out FDAs LDT Rule

[ Price : $8.95]

The American Clinical Laboratory Association and its fellow plaintiffs ask a Texas federal court to grant summary judgment in favo...

SoloVital Illegally Marketing Hyaluronic Acid: FDA

[ Price : $8.95]

FDA warns Chula Vista, CA-based SoloVital it is marketing a misbranded and unapproved hyaluronic acid drug product as a dietary su...

California Man Pleads Guilty to Illegal Etizolam Sales

[ Price : $8.95]

The Department of Justice says Californian Paul Lamberty pleaded guilty in a Massachusetts federal court to conspiracy to defraud ...

Vanda Sues FDA Over Pending Tradipitant NDA Decision

[ Price : $8.95]

Vanda Pharmaceuticals sues FDA, seeking an advisory committee meeting to assess the companys pending NDA for tradipitant and its u...

Zynex TensWave for Pain Cleared

[ Price : $8.95]

FDA clears a Zynex 510(k) for its TensWave, a transcutaneous electrical nerve stimulation therapy for reducing chronic and acute p...

Ventis Emergency Transport Ventilator Cleared

[ Price : $8.95]

FDA clears a Ventis Medical 510(k) for the VM-2000, an emergency transport ventilator that allows medical personnel to provide res...

Otsuka Pharmaceutical FDA-483 Released

[ Price : $8.95]

FDA releases the form FDA-483 with five observations from an inspection at the Otsuka Pharmaceutical second factory in Tokushima, ...