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Hospira Holds Symbiq Pump Shipments

[ Price : $8.95]

Hospira tells the SEC it is suspending shipment of Symbiq infusion pumps to U.S. customers due to an FDA import alert.

Opana ER Reducing Abuse, Endo Says

[ Price : $8.95]

Endo tells FDA that its reformulated Opana ER has reduced opioid drug abuse.

Some Whistleblower Records Properly Withheld: Court

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A DC federal court rules that HHS acted properly in redacting and withholding some documents sought by CDRH whistleblowers.

Academic Groups Air Biosimilar Patent Concern

[ Price : $8.95]

Leaders of six higher education associations ask FDA for a requirement that biosimilar applicants certify their compliance with th...

Reviewers Say Dynavax Hep B Vaccine is Effective

[ Price : $8.95]

CBER clinical reviewers tell the Vaccines and Related Biological Products Advisory Committee that Dynavax Technologies Heplisav ap...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites The Avalon Effect, Health Breakthroughs, I. Shay Cosmetics, Mushroon Wisdom, and...

FDA Clears Cerner FetaLink Surveillance System

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FDA clears a Cerner 510(k) for its FetaLink+, a solution that provides clinicians access to maternal and fetal surveillance inform...

Ikaria Software Upgrade for Inomax Drug Delivery System

[ Price : $8.95]

FDA clears an Ikaria 510(k) for a software upgrade to enable connectivity of the Inomax DSIR drug delivery system with hospital he...

Group Wants Harmonized API Regs

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The European Fine Chemicals Group calls for global harmonization of active pharmaceutical ingredient rules and regulations.

FDA OKs Medtronics Valiant Captivia Stent for Aortic Injuries

[ Price : $8.95]

FDA approves Medtronics Valiant Captivia stent graft system for repairing blunt traumatic aortic injuries.