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16 Observations in Pharm D Solutions FDA-483

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FDA releases the FDA-483 with 16 observations from an inspection at the Pharm D Solutions outsourcing facility.

Neurelis NDA for Epilepsy Nasal Spray

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Neurelis files an NDA for Valtoco (diazepam nasal spray) as a treatment for epilepsy in patients six years and older who experienc...

Renovid Surgical 3D-printed Interbody Fusion System Cleared

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FDA clears a Renovis Surgical Technologies 510(k) to market the Tesera X Lateral Interbody Fusion System.

FDA Publishes 3 Drug Compounding Guidances

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FDA issues three guidances relating to insanitary conditions at drug compounding facilities and to repackaging or compounding of r...

Tropical Disease Priority Review Fee is $2.46 Million

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Federal Register notice: FDA announces the fee rate for using a tropical disease priority review voucher for fiscal year 2019 $2....

Ultrasound Cyclodestructive Device Reclassification Proposed

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Federal Register notice: FDA issues a proposed order to reclassify the ultrasound cyclodestructive device, a postamendments Class ...

FDA Clears Synergy Biomedicals Biosphere Flex

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FDA clears a Synergy Biomedical 510(k) for the Biosphere Flex, a strip-format bone graft product made of porous, bioactive glass.

Factors in Pivotal Trial Costs

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Researchers say pivotal clinical trials often are not the main reason for the high cost of drug development.

CGMP Violations at Wilson Medicine Co.

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FDA warns Indias Wilson Medicine Co. about CGMP violations in the production of finished drugs.

FDA Publishes 3 Drug Compounding Guidances

[ Price : $8.95]

FDA issues three guidances relating to insanitary conditions at drug compounding facilities and to repackaging or compounding of r...