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FDA Clears Quidel Hand-held Pertussis Diagnostic

[ Price : $8.95]

FDA clears a Quidel Corp. hand-held AmpliVue Bordetella Assay for detecting Bordetella pertussis.

CDER Approvals Up 30% in 2014: Jenkins

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CDER Office of New Drugs director John Jenkins says the Center has approved 35 new molecular entity submissions through 12/3, a 30...

Approved Cattle FSH Drug Available

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FDA says it has approved Bioniche Animal Healths Folltropin for use to reduce superovulation for beef and dairy heifers and cows.

Ex-FDA Chief of Staff Moves to DC Law Firm

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Former FDA chief of staff Lisa Barclay joins the law firm Boies, Schiller & Flexner as counsel in its Washington, DC, office.

FDA Guidance on Safety of Implants Near Magnetic Resonance

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FDA releases a final guidance on Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance Environment.

Stericycle Sees Unsure Medical Device Recall Future

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Stericycle says a number of factors lead to an uncertain future for medical device recalls.

Sanofi Hit with New Legal Action

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CNBC reports that Sanofi is facing a new whistleblower suit over money kickbacks to induce use of diabetes drugs and a shareholder...

Geodon Associated with Rare Skin Reaction: FDA

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FDA says that Pfizers antipsychotic Geodon and its generics can cause a rare but serious skin reaction known as drug reaction with...

FDA Using Rapid Screening Devices on Drug Imports

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FDA says it is field testing new methods for four screening devices to detect toxic metals and other impurities in dietary supplem...

FDA Approves Medtronic Left Ventricular Leads

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FDA approves a Medtronic PMA for two additional Attain Performa left ventricular quadripolar leads, which can be paired with the M...