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Oculus Microcyn Scar Gel Cleared by FDA

[ Price : $8.95]

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...

Draft Guidance on BE Studies for Some ANDAs

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FDA issues a draft guidance on bioequivalence studies for certain ANDAs and supplements.

FDA Says Tris Pharma Not Complying with PREA for Nexiclon

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FDA says Tris Pharma has failed to comply with pediatric assessment requirements for its Nexiclon.

Orphan Status for Kinex Brain Cancer Drug

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FDA grants Kinex Pharmaceuticals an orphan drug designation for KX02 for treating gliomas.

FDA Releases Info on 9 Safety Evaluations

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FDA releases its postmarket safety evaluations on nine drugs completed earlier this year.

FDA Releases Meridian Medical Inspection Report

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FDA releases the FDA-483 from a March-April inspection at Meridian Medical Technologies.

Info on Biological Product Deviations Sent to OMB

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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.