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FDA Grants Arzerra Breakthrough Status

[ Price : $8.95]

FDA grants Genmab and GlaxoSmithKline a breakthrough therapy designation for Arzerra (ofatumumab) in combination with chlorambucil...

Hospira Recalls Bupovacaine Due to Particulates

[ Price : $8.95]

Hospira recalls one lot of 0.25% bupivacaine HCl Injection, USP (2.5 mg/mL), 30 mL single-dose vials due to the presence of partic...

FDA Slaps Ranbaxy with Consent Decree Terms at Another Facility

[ Price : $8.95]

FDA places another Ranbaxy drug manufacturing plant in India under terms of a 2012 consent decree after two inspections last year ...

FDA Clears Vital Access Vascular Needle Guide

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FDA clears a Vital Access Corp. 510(k) for its Vwing Vascular Needle Guide for patients undergoing dialysis.

Millennium Seeks Higher Approval Bar on Fresenius Velcade Copy

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Millennium Pharmaceuticals petitions FDA seeking additional pre-approval requirements on a Fresenius 505(b)(2) NDA for bortezomib ...

Guidance on Bioanalytical Method Validation

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Federal Register Notice: FDA releases a draft guidance: Bioanalytical Method Validation.

Bipartisan Drug Compounding Bill Introduced in House

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A bipartisan group of House lawmakers introduce a bill that would clarify FDAs authority over large-scale pharmacy drug compoundin...

FDA Clears NeoTract UroLift System

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FDA clears a de novo 510(k) for NeoTracts UroLift system, the first permanent implant to relieve low or blocked urine flow in men ...

Group Calls for Measured NSAID Use as Opioid Alternative

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The Alliance for Rational Use of NSAIDs reminds consumers of proper NSAID usage in case they use them as alternatives to opioid an...

Info on Electronic Labeling for Drugs, Biologics Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on labeling for prescription drugs and biologics in elec...