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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 IRB Recordkeeping

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Federal Register Notice: FDA seeks comments on recordkeeping requirements for institutional review boards.

Comments Extended on Product Application Data Availability

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Federal Register Notice: FDA extends the comment period on a 6/4 Federal Register notice on the proposed availability of de-identi...

No FDA Product Submissions with Fees Until Budget Passes

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During the current budget impasse on Capitol Hill and partial government shutdown, FDA says it cannot accept medical product submi...

IDE Early Feasibility Study Guidance

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FDA issues a guidance on developing and reviewing IDE applications for early feasibility studies of significant risk devices.

Comments Sought on Biologics Communication Studies

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Federal Register Notice: FDA seeks comments on a proposed collection of information on studies about biological product communicat...

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 ...

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...