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Panel to Hear Retrovirus, Immunoregulation Research

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Federal Register Notice: FDAs Vaccines and Related Biological Products Advisory Committee will meet 11/13 to hear an overview of r...

FDA Clears StemCells IND for Spinal Cord Injury

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FDA approves a StemCells, Inc. IND application for clinical testing of its HuCNS-SC human neural stem cells for treating chronic s...

FDA Continues Delaying Action on Zogenix Zohydro

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FDA tells Zogenix there will be another short delay before it issues an action letter on the companys NDA for Zohydro ER.

Advisors to Consider Relistor sNDA

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FDA schedules an advisory committee meeting for March 2014 on a Salix sNDA for a broadened indication for Relistor.

Consider ANDA Petitions Carefully: Attorney

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Attorney Bruce Manheim raises issues companies should resolve when considering a citizen petition or lawsuit against FDA over a ge...

15 Medtronic MiniMed QS, MDR Violations Noted

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FDA releases a 15-violation Warning Letter it sent to Medtronic MiniMed about Quality System and Medical Device Reporting violatio...

CareFusion Recalls Avea Ventilators

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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

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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 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...