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Trevena Given Fast Track for Novel Pain Drug

[ Price : $8.95]

FDA grants Trevena a fast track designation for oliceridine (TRV130) for managing moderate-to-severe acute pain.

Sun Pharma Gains FDA OK for Generic Gleevec

[ Price : $8.95]

FDA approves a Sun Pharmaceutical Industries ANDA for generic versions of Novartis chronic myeloid leukemia treatment Gleevec (ima...

FDA Alert Warns About Lipo Escultura

[ Price : $8.95]

An FDA safety alert says Lipo Escultura Corp. (Brooklyn, NY) is recalling all Lipo Escultura dietary supplement products because, ...

CDRH Safety Communications Up

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Qmed Daily says the number of CDRH medical device safety communications this year rose substantially over the numbers in 2014 and ...

eCopy Program Submission Guidance

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FDA issues an updated final guidance on eCopy submission standards for medical devices.

Start Quality Metrics Targeted Program: ISPE

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The International Society for Pharmaceutical Engineering calls on FDA to use a targeted, phased-in approach to start its quality m...

FasterCures Suggestions for Patient Perspective Info

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FasterCures recommends PDUFA 6 language to build collection of patient perspective data into medical product development and regul...

Concordia Wants Changes for Generic Digoxin Drugs

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Concordia asks FDA to update its digoxin bioequivalence guidance with testing recommendations from an advisory committee.

Researchers Identify New Lung Cancer Biomarker

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Researchers in Taiwan say they have identified a biomarker that detects the most common lung cancer in its earliest stage, which c...

FDA Clears Gmate Smartphone Blood Glucose Monitor

[ Price : $8.95]

FDA clears a Philosys 510(k) for the Gmate Smart Blood Glucose Monitoring System and app for Android smartphones.