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Lupron Depot-Ped Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Lupron Depot-Ped Injectable 3.75 mg/vial and 7.5 mg/vial; and 7.5 mg/vial and 7.5 mg/...

CDRH Posts UDI Frequently-asked Questions Guidance

[ Price : $8.95]

CDRH posts a guidance on Unique Device Identification (UDI) System: Frequently Asked Questions, Vol. 1 Guidance for Industry and F...

FDA Loses Against Hospira in Precedex Carve-out Decision

[ Price : $8.95]

The Maryland federal district court grants Hospira a temporary restraining order against FDA after the company challenged an agenc...

Marck Biosciences Changes Its Name

[ Price : $8.95]

A European Compliance Academy online newsletter discloses that Indias Marck Biosciences changed its name shortly before a very cri...

FDA Speeding PMA Approvals: Analysis

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EPVantages Medtech review of the first half of 2014 says that FDA is speeding PMA approvals and planning an expedited review for i...

FDA Seeks Advisory Panel Consumer Reps

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Federal Register Notice: FDA seeks those interested in participating in selecting consumer representatives and nominations for con...

Cardiovascular Systems Class 1 Recall of Atherectomy System

[ Price : $8.95]

Cardiovascular Systems begins a Class 1 recall of its Diamondback 360 Peripheral Orbital Atherectomy System.

FDA Approves GSK Once-daily Asthma Treatment

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FDA approves GlaxoSmithKlines Arnuity Ellipta for once-daily maintenance treatment of asthma as prophylactic therapy in patients a...

8th Circuit Affirms Stryker, I-Flow Case Dismissal

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The 8th Circuit Court of Appeals upholds a lower courts dismissal of an orthopedic surgeons False Claims Act suit against Stryker ...

CGMP Violations Found at Indias Marck Biosciences

[ Price : $8.95]

FDA warns Indias Marck Biosciences about CGMP violations in its production of finished pharmaceuticals.