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Prison Term for Supplement Adulteration

[ Price : $8.95]

The president of the Raw Deal dietary supplement manufacturing firm is sentenced to 40 months in prison for selling diluted and ad...

Multinational Single Audit Pilot on Schedule: CDRH

[ Price : $8.95]

CDRH says that its multinational Medical Device Single Audit Program is on schedule in the middle of its pilot for all objectives ...

Lumicell Gets FDA OK for Gastrointestinal Cancers Study

[ Price : $8.95]

FDA approves a Lumicell feasibility study of its intraoperative imaging system for imaging tissue in patients with esophageal, col...

FDA Accepts First Digital Medicine NDA

[ Price : $8.95]

FDA accepts for review an Otsuka Pharmaceutical Co. and Proteus Digital Health NDA for the combination product of Abilify (aripipr...

FDA Accepts IND for Systemic Mastocytosis Trial

[ Price : $8.95]

FDA accepts an IND application from Blueprint Medicines to begin a Phase 1 clinical trial of BLU-285 in patients with advanced sys...

Senators Go After Pay-for-Delay Agreements

[ Price : $8.95]

Sens. Klobuchar and Grassley reintroduce legislation to end so-called pay-for-delay agreements between innovator and generic drug ...

Medistat RX Recalls All Sterile Products

[ Price : $8.95]

FDA says that Medistat RX has ceased sterile compounding operations and is recalling all non-expired products produced for sterile...

Class 1 Recall of OmniPod Insulin Pump

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FDA classifies as Class 1 a recall by Insulet Corp. of its OmniPod Insulin Management System due to insulin delivery issues.

Animal Drug Distributor Labeling Guidance

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FDA issues a guidance describing the factors it considers in taking regulatory action against animal drug distributors whose label...

Questions, Concerns on Device Expedited Access

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Stakeholders offer suggestions for improving an FDA draft program to expedite access to innovative medical devices.