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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.

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Federal Register Notice: FDA releases a draft guidance: Interim Product Reporting for Human Drug Compounding Outsourcing Facilitie...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Federal Register Notice: FDA releases a draft guidance: Registration for Human Drug Compounding Outsourcing Facilities Under Secti...