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CareFusion Recalls Avea Ventilators

[ Price : $8.95]

CareFusion begins a Class 1 recall of its Avea ventilators because they may experience an under-reporting of tidal volume if used ...

Cerus Files PMA Module InterCept Blood Platelet System

[ Price : $8.95]

Cerus Corp. files the first of three PMA modules for its InterCept Blood System for platelets.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites C.P.M. Contract Pharma, Dolgencorp, Epflex Feinwerktechnik, Medtronic MiniMed, N...

Comments Sought on Citizen Petitions Guidance

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Federal Register Notice: FDA seeks comments on a proposed collection of information contained in a guidance on citizen petitions a...

Drug, Device Violations in Sale of OTC Asthmanefrin

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FDAs Florida District Office warns Nephron Pharmaceuticals that its Asthmanefrin is an unapproved new drug being marketed inapprop...

Multiple QS Violations at German Epflex Firm

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FDA warns Germans Epflex Feinwerktechnik about Quality System Regulation violations in its manufacturing of guidewire devices.

United Therapeutics Backs Actelion Generic Ventavis Petition

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United Therapeutics tells FDA it supports Actelions petition asking that any generic Ventavis be approved with a nebulizer that ha...

Guidance on Early Feasibility Device Studies

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Federal Register Notice: FDA releases a guidance: Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Cl...

Guidance on ANDA Submissions Standards

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Federal Register Notice: FDA releases a draft guidance: ANDA Submissions Refuse-to-Receive Standards.

Amgen Reports Positive Trial Data with Melanoma Therapy

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Amgen reports positive results from a pivotal Phase 3 trial evaluating talimogene laherparepvec in patients with unresected Stage ...