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Comments Sought on Device User Fee Form

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on the medical device user fee cover sheet, which must be submitted along with certain...

Info on Reducing Tobacco Use Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on the agencys campaign to reduce tobacco use among gay,...

OMB OKs Info on Formal Evidentiary Hearing

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Federal Register Notice: The Office of Management and Budget approves a collection of information on administrative practices and ...

FDA Clears Cepheid Xpert TV Test

[ Price : $8.95]

FDA clears a Cepheid 510(k) to market Xpert TV, a qualitative in vitro diagnostic test for identifying Trichomoniasis in symptomat...

Downing Labs Recalls Compounded Products

[ Price : $8.95]

Downing Labs recalls all lots of sterile products compounded and packaged by the firm due to concerns over sterility assurance.

OMB OKs Info on Device Reclassification Petitions

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Federal Register Notice: The Office of Management and Budget approves a collection of information on device reclassification petit...

Comments Sought on Detention/Banned Devices

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on an information collection on administrative detention and banned medical devices.

Meeting on Womens Health Strategic Priorities

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Federal Register Notice: FDA plans a meeting 11/30: Office of Womens Health General Update on Strategic Priorities and Initiatives...

New REMS Resource Opened

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The new Patients Alliance for Drug Safety Protections opens an online resource on the benefits of REMS.

Otsuka Suing FDA Over Aristada Approval

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Otsuka asks a federal court to reverse FDAs decision to approve an Alkermes NDA for Aristada.