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Info on Biological Product Deviations Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on biological product deviations and human cells, tissue...

Teva Wants Dose Counters in Rescue Inhalers

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Teva asks FDA to require integrated dose counters in all new and already marketed metered-dose inhaler products.

FDA Sends Info on Device Third Party Review to OMB

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Federal Register Notice: FDA sends a proposed collection of information on device third party review to the Office of Management a...

FDA Sends Info on Human Tissue to OMB

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Federal Register Notice: FDA submits a proposed collection of information on human tissue intended for transplantation to the Offi...

Guidance on Compounding Reporting

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Federal Register Notice: FDA releases a draft guidance: Interim Product Reporting for Human Drug Compounding Outsourcing Facilitie...

Guidance on Registration for Compounding Outsourcing Facilities

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Federal Register Notice: FDA releases a draft guidance: Registration for Human Drug Compounding Outsourcing Facilities Under Secti...

Oculus Microcyn Scar Gel Cleared by FDA

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FDA clears an Oculus Innovative Sciences 510(k) for its Microcyn Scar Management HydroGel and its use in managing old and new hype...

Consultants Say Law on Labeling Changes Should be Revised

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Cornerstone Regulatory suggests that FDA encourage changes to the laws governing safety labeling changes so it can use the Adverse...

FDA Reaches Settlement Against ASP Over Device Shelf Life

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FDA reaches a $1.25 million civil money penalty settlement against Johnson & Johnsons Advanced Sterilization Products (ASP) and tw...

CGMP Violations Found in Allergy Laboratories Inspection

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FDA warns Allergy Laboratories about CGMP violations indicating the firms quality control units are not fulfilling their responsib...