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Package Type Guidance Out

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FDA issues a draft guidance revising definitions for packaging types and adding a new definition.

Stop Apotex Neulasta Biosim, Amgen Asks Court

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Amgen asks a Florida federal court to approve an injunction barring Apotex from marketing its Neulasta biosimilar until it gives a...

AZs Lesinurad Side Effects Raised for Committee

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FDA medical reviewers tell the Arthritis Advisory Committee that they have questions about the safety of AstraZenecas new gout dru...

Comments Sought on Device User Fee Form

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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

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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

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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

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

Prize Competition to Further Open Science

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The National Institutes of Health announces a global competition to find new products or services to advance open science.

Comments Sought on Supplement AERs/Recordkeeping Info

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Federal Register Notice: FDA seeks comments on a collection of information associated with adverse event reporting and recordkeepi...